Trial Outcomes & Findings for Healthy Mom Zone: A Gestational Weight Gain Management Intervention (NCT NCT03945266)

NCT ID: NCT03945266

Last Updated: 2023-05-24

Results Overview

Gestational weight change will be measured daily at home using the FitBit Aria Wi-Fi Smart Scale (www.fitbit.com; weights will be wirelessly uploaded to online program). Gestational weight change will be standardized: target weight gain will be determined for each woman based on BMI (kg/m\^2) status (OW = 15-25 lb, OB = 11-20 lb). For the criterion measure to determine when to adapt the intervention, weight gain will be calculated to determine if a woman is gaining \< her goal (-), at the exact amount of her goal (0), or \> her goal (+). Pre-pregnancy weight and gestational weight change from the first prenatal visit to the last pre-delivery weight will also be obtained from clinical records. Overweight/obese pregnant women (OW/OBPW) often exceed the GWG guidelines, managing weight gain in this population is critical. Participants weigh themselves daily using a WiFi connected scale. Outcome measure reported at mean change from pre- to post-intervention.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 31 participants
• Primary outcome timeframe: Daily data was collected starting at baseline (pre-intervention), through study completion Month 6 (post-intervention). Also measured daily for one week at 6-weeks postpartum. Outcome measure reported at mean change from pre- to post-intervention.
• Results posted on: 2023-05-24

Participant Flow

Participant milestones

Measure	Intervention Group Participants receive the allocated intervention to help manage gestational weight gain that includes education on weight regulation, healthy eating, physical activity, and goal setting. Intervention group: During the intervention, all participants will start out at the Baseline level. The baseline level will last 2 weeks and there will be an assessment to determine weight gain over those 2 weeks. If weight gain has succeeded the recommended amount, participants will be adapted up to a new level of intervention that includes education on GWG, healthy eating and physical activity. After every 4 weeks, an assessment will be performed and adaptations up will be made if necessary. Adaptations include addition of exercise sessions, healthy eating recipe demonstrations, and meal replacements. Participants will weigh themselves daily, wear an activity monitor, record their diet, and complete paper and online surveys.	Control Group Participants do not receive the allocated intervention but self-monitor their behaviors, complete study tasks and receive prenatal care as normal. Control group: Participants will follow the same self-monitoring/assessment schedule but will not receive the GWG, healthy eating, and physical activity education or adaptations.
Overall Study STARTED	15	16
Overall Study COMPLETED	13	14
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Measure	Intervention Group Participants receive the allocated intervention to help manage gestational weight gain that includes education on weight regulation, healthy eating, physical activity, and goal setting. Intervention group: During the intervention, all participants will start out at the Baseline level. The baseline level will last 2 weeks and there will be an assessment to determine weight gain over those 2 weeks. If weight gain has succeeded the recommended amount, participants will be adapted up to a new level of intervention that includes education on GWG, healthy eating and physical activity. After every 4 weeks, an assessment will be performed and adaptations up will be made if necessary. Adaptations include addition of exercise sessions, healthy eating recipe demonstrations, and meal replacements. Participants will weigh themselves daily, wear an activity monitor, record their diet, and complete paper and online surveys.	Control Group Participants do not receive the allocated intervention but self-monitor their behaviors, complete study tasks and receive prenatal care as normal. Control group: Participants will follow the same self-monitoring/assessment schedule but will not receive the GWG, healthy eating, and physical activity education or adaptations.
Overall Study Withdrawal by Subject	1	0
Overall Study Miscarriage	0	2
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Healthy Mom Zone: A Gestational Weight Gain Management Intervention

Baseline characteristics by cohort

Measure	Intervention Group n=15 Participants Participants receive the allocated intervention to help manage gestational weight gain that includes education on weight regulation, healthy eating, physical activity, and goal setting. Intervention group: During the intervention, all participants will start out at the Baseline level. The baseline level will last 2 weeks and there will be an assessment to determine weight gain over those 2 weeks. If weight gain has succeeded the recommended amount, participants will be adapted up to a new level of intervention that includes education on GWG, healthy eating and physical activity. After every 4 weeks, an assessment will be performed and adaptations up will be made if necessary. Adaptations include addition of exercise sessions, healthy eating recipe demonstrations, and meal replacements. Participants will weigh themselves daily, wear an activity monitor, record their diet, and complete paper and online surveys.	Control Group n=16 Participants Participants do not receive the allocated intervention but self-monitor their behaviors, complete study tasks and receive prenatal care as normal. Control group: Participants will follow the same self-monitoring/assessment schedule but will not receive the GWG, healthy eating, and physical activity education or adaptations.	Total n=31 Participants Total of all reporting groups
Age, Continuous	29.7 years STANDARD_DEVIATION 3.7 • n=5 Participants	29.6 years STANDARD_DEVIATION 4.5 • n=7 Participants	29.6 years STANDARD_DEVIATION 4.1 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	16 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	16 participants n=7 Participants	31 participants n=5 Participants
Pre-pregnancy BMI	32.4 kg/m^2 STANDARD_DEVIATION 7.6 • n=5 Participants	32.7 kg/m^2 STANDARD_DEVIATION 7.0 • n=7 Participants	32.6 kg/m^2 STANDARD_DEVIATION 7.2 • n=5 Participants
Pre-pregnancy Weight	86.4 kilograms STANDARD_DEVIATION 20.0 • n=5 Participants	91.2 kilograms STANDARD_DEVIATION 22.4 • n=7 Participants	88.9 kilograms STANDARD_DEVIATION 21.0 • n=5 Participants
Weight at Study Enrollment	87.2 kilograms STANDARD_DEVIATION 19.8 • n=5 Participants	92.4 kilograms STANDARD_DEVIATION 21.0 • n=7 Participants	89.9 kilograms STANDARD_DEVIATION 20.2 • n=5 Participants
Gestational Age	10.3 weeks STANDARD_DEVIATION 1.6 • n=5 Participants	10.1 weeks STANDARD_DEVIATION 1.7 • n=7 Participants	10.2 weeks STANDARD_DEVIATION 4.5 • n=5 Participants

PRIMARY outcome

Timeframe: Daily data was collected starting at baseline (pre-intervention), through study completion Month 6 (post-intervention). Also measured daily for one week at 6-weeks postpartum. Outcome measure reported at mean change from pre- to post-intervention.

Gestational weight change will be measured daily at home using the FitBit Aria Wi-Fi Smart Scale (www.fitbit.com; weights will be wirelessly uploaded to online program). Gestational weight change will be standardized: target weight gain will be determined for each woman based on BMI (kg/m^2) status (OW = 15-25 lb, OB = 11-20 lb). For the criterion measure to determine when to adapt the intervention, weight gain will be calculated to determine if a woman is gaining < her goal (-), at the exact amount of her goal (0), or > her goal (+). Pre-pregnancy weight and gestational weight change from the first prenatal visit to the last pre-delivery weight will also be obtained from clinical records. Overweight/obese pregnant women (OW/OBPW) often exceed the GWG guidelines, managing weight gain in this population is critical. Participants weigh themselves daily using a WiFi connected scale. Outcome measure reported at mean change from pre- to post-intervention.

Outcome measures

Measure	Intervention Group n=13 Participants Participants receive the allocated intervention to help manage gestational weight gain that includes education on weight regulation, healthy eating, physical activity, and goal setting. Intervention group: During the intervention, all participants will start out at the Baseline level. The baseline level will last 2 weeks and there will be an assessment to determine weight gain over those 2 weeks. If weight gain has succeeded the recommended amount, participants will be adapted up to a new level of intervention that includes education on GWG, healthy eating and physical activity. After every 4 weeks, an assessment will be performed and adaptations up will be made if necessary. Adaptations include addition of exercise sessions, healthy eating recipe demonstrations, and meal replacements. Participants will weigh themselves daily, wear an activity monitor, record their diet, and complete paper and online surveys.	Control Group n=14 Participants Participants do not receive the allocated intervention but self-monitor their behaviors, complete study tasks and receive prenatal care as normal. Control group: Participants will follow the same self-monitoring/assessment schedule but will not receive the GWG, healthy eating, and physical activity education or adaptations.
Gestational Weight Change	6.9 kilograms Interval 3.8 to 10.0	8.8 kilograms Interval 5.1 to 12.3

SECONDARY outcome

Timeframe: Data was collected each month starting at baseline (pre-intervention), through study completion at Month 6 (post-intervention). Pre-intervention, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, post-intervention.

The Theory of Planned Behavior will inform our dynamical model in order to create individualized interventions for OW/OBPW. Beliefs: These items were developed to assess Theory of Planned Behavior (TPB) behavioral, control, and normative beliefs. Main Constructs: The Theory of Planned Behavior (TPB) Healthy Eating Main Constructs measure is a 38-item measure developed to assess the main constructs of the TPB (i.e., attitude, subjective norm (SN), perceived behavioral control (PBC), intention) as they relate to healthy eating behavior. Scoring for the TPB is the sum of each subscale. Attitude and Limit Attitude range of scores: 7-49 - higher score means greater/more positive attitude; SN and Limit SN range: 3-21 - higher score greater/more positive subjective norm; PBC and Limit PBC range: 3-21 - higher score greater/more positive PBC; Intention range: 6-42 - higher score greater/more positive intention. Results reported reflect mean changes from pre-intervention to post-intervention.

Outcome measures

Measure	Intervention Group n=13 Participants Participants receive the allocated intervention to help manage gestational weight gain that includes education on weight regulation, healthy eating, physical activity, and goal setting. Intervention group: During the intervention, all participants will start out at the Baseline level. The baseline level will last 2 weeks and there will be an assessment to determine weight gain over those 2 weeks. If weight gain has succeeded the recommended amount, participants will be adapted up to a new level of intervention that includes education on GWG, healthy eating and physical activity. After every 4 weeks, an assessment will be performed and adaptations up will be made if necessary. Adaptations include addition of exercise sessions, healthy eating recipe demonstrations, and meal replacements. Participants will weigh themselves daily, wear an activity monitor, record their diet, and complete paper and online surveys.	Control Group n=14 Participants Participants do not receive the allocated intervention but self-monitor their behaviors, complete study tasks and receive prenatal care as normal. Control group: Participants will follow the same self-monitoring/assessment schedule but will not receive the GWG, healthy eating, and physical activity education or adaptations.
Theory of Planned Behavior (Motivational Determinants of Healthy Eating) Attitude	-1.8 score on a scale Interval -4.2 to 0.6	-2.5 score on a scale Interval -4.8 to -0.2
Theory of Planned Behavior (Motivational Determinants of Healthy Eating) Subjective Norm	0.0 score on a scale Interval -1.4 to 1.4	-1.4 score on a scale Interval -2.7 to -0.1
Theory of Planned Behavior (Motivational Determinants of Healthy Eating) Perceived Behavioral Control	-0.8 score on a scale Interval -2.1 to 0.4	-0.3 score on a scale Interval -1.5 to 0.9
Theory of Planned Behavior (Motivational Determinants of Healthy Eating) Intention	-2.1 score on a scale Interval -4.8 to 0.7	-3.2 score on a scale Interval -5.8 to -0.7
Theory of Planned Behavior (Motivational Determinants of Healthy Eating) Limit Unhealthy Eating Attitude	-0.2 score on a scale Interval -3.4 to 2.9	-0.9 score on a scale Interval -3.9 to 2.0
Theory of Planned Behavior (Motivational Determinants of Healthy Eating) Limit Unhealthy Eating Subjective Norm	0.0 score on a scale Interval -2.7 to 0.6	-0.9 score on a scale Interval -2.6 to 0.8
Theory of Planned Behavior (Motivational Determinants of Healthy Eating) Limit Unhealthy Eating Perceived Behavioral Control	0.0 score on a scale Interval -1.6 to 1.7	-0.8 score on a scale Interval -2.4 to 0.8
Theory of Planned Behavior (Motivational Determinants of Healthy Eating) Limit Unhealthy Eating Intention	-0.6 score on a scale Interval -3.9 to 2.6	-2.9 score on a scale Interval -6.0 to 0.3

SECONDARY outcome

Timeframe: Data was collected each month starting at baseline (pre-intervention), through study completion at post-intervention - Pre-intervention, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, post-intervention.

The Theory of Planned Behavior will inform our dynamical model in order to create individualized interventions for OW/OBPW. Beliefs: These items were developed to assess Theory of Planned Behavior (TPB) behavioral, control, and normative beliefs. Main Constructs: The Theory of Planned Behavior (TPB) Healthy Eating Main Constructs measure is a 38-item measure developed to assess the main constructs of the TPB (i.e., attitude, subjective norm (SN), perceived behavioral control (PBC), intention) as they relate to healthy eating behavior. Scoring for the TPB is the sum of each subscale. Attitude range of scores: 7-49 - higher score means greater/more positive attitude; SN range: 3-21 - higher score greater/more positive subjective norm; PBC range: 3-21 - higher score greater/more positive PBC; Intention range: 6-42 - higher score greater/more positive intention. Results reported reflect mean changes from pre-intervention to post-intervention.

Outcome measures

Measure	Intervention Group n=13 Participants Participants receive the allocated intervention to help manage gestational weight gain that includes education on weight regulation, healthy eating, physical activity, and goal setting. Intervention group: During the intervention, all participants will start out at the Baseline level. The baseline level will last 2 weeks and there will be an assessment to determine weight gain over those 2 weeks. If weight gain has succeeded the recommended amount, participants will be adapted up to a new level of intervention that includes education on GWG, healthy eating and physical activity. After every 4 weeks, an assessment will be performed and adaptations up will be made if necessary. Adaptations include addition of exercise sessions, healthy eating recipe demonstrations, and meal replacements. Participants will weigh themselves daily, wear an activity monitor, record their diet, and complete paper and online surveys.	Control Group n=14 Participants Participants do not receive the allocated intervention but self-monitor their behaviors, complete study tasks and receive prenatal care as normal. Control group: Participants will follow the same self-monitoring/assessment schedule but will not receive the GWG, healthy eating, and physical activity education or adaptations.
Theory of Planned Behavior (Motivational Determinants of Physical Activity) Physical Activity Attitude	-2.9 change score on a scale Interval -8.2 to 2.5	-1.1 change score on a scale Interval -6.2 to 3.9
Theory of Planned Behavior (Motivational Determinants of Physical Activity) Physical Activity Subjective Norm	-0.2 change score on a scale Interval -3.0 to 2.5	0.3 change score on a scale Interval -2.3 to 2.9
Theory of Planned Behavior (Motivational Determinants of Physical Activity) Physical Activity Perceived Behavioral Control	-0.7 change score on a scale Interval -3.0 to 1.5	1.5 change score on a scale Interval -0.7 to 3.7
Theory of Planned Behavior (Motivational Determinants of Physical Activity) Physical Activity Intention	1.8 change score on a scale Interval -1.2 to 4.7	-1.9 change score on a scale Interval -4.9 to 1.0

SECONDARY outcome

Timeframe: Data was collected bi-weekly starting at baseline (pre-intervention), through study completion at Month 6 (post-intervention). Pre-intervention week, week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, and post-intervention week.

Self-regulation of HE will be measured in order to inform our dynamical model and to how well OW/OBPW are at regulating their energy intake and expenditure and how it impacts their GWG.

These items were taken from Ryan Rhodes items for self-regulation of PA and adapted for HE behaviors. Ryan has indicated that these items work really well as an index for HE self-regulation because these behaviors are naturally inter-connected but to look at specific self-regulatory behaviors: self-monitoring, goal-setting, action planning, coping planning, scheduling, affective There are also 2 sets of 8 questions-first 8 examine prospective behaviors while the second set assesses retrospective behaviors.

Retrospective scores range from 11-55 and Prospective scores range from 11-55. Total scores range from 22-110. A higher score indicates higher levels of HE self-regulation. Results are mean difference of pre- and post-intervention week.

Outcome measures

Measure	Intervention Group n=13 Participants Participants receive the allocated intervention to help manage gestational weight gain that includes education on weight regulation, healthy eating, physical activity, and goal setting. Intervention group: During the intervention, all participants will start out at the Baseline level. The baseline level will last 2 weeks and there will be an assessment to determine weight gain over those 2 weeks. If weight gain has succeeded the recommended amount, participants will be adapted up to a new level of intervention that includes education on GWG, healthy eating and physical activity. After every 4 weeks, an assessment will be performed and adaptations up will be made if necessary. Adaptations include addition of exercise sessions, healthy eating recipe demonstrations, and meal replacements. Participants will weigh themselves daily, wear an activity monitor, record their diet, and complete paper and online surveys.	Control Group n=14 Participants Participants do not receive the allocated intervention but self-monitor their behaviors, complete study tasks and receive prenatal care as normal. Control group: Participants will follow the same self-monitoring/assessment schedule but will not receive the GWG, healthy eating, and physical activity education or adaptations.
Self-regulation of Healthy Eating Healthy Eating Prospective Self-Regulation	-3.3 score on a scale Interval -6.9 to 0.4	-3.5 score on a scale Interval -7.1 to 0.1
Self-regulation of Healthy Eating Healthy Eating Retrospective Self-Regulation	1.6 score on a scale Interval -3.0 to 6.1	4.5 score on a scale Interval -0.1 to 9.0

SECONDARY outcome

Timeframe: Data was collected bi-weekly starting at baseline (pre-intervention), through study completion at Month 6 (post-intervention). Pre-intervention week, week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, and post-intervention week.

Self-regulation of PA will be measured in order to inform our dynamical model and to how well OW/OBPW are at regulating their energy intake and expenditure and how it impacts their GWG. These items are taken from Ryan Rhodes. Ryan has indicated that these items work really well as an index because these behaviors are naturally inter-connected but to look at specific self-regulatory behaviors: Item #1: self-monitoring, Item #2: goal-setting, Item # 3: action planning, Item #4: coping planning, Item #5: scheduling, Item #6, 7, 8, 9: cuing, Items 10 & 11: affective. There are also 2 sets of 8 questions-first 8 examine prospective behaviors while the second set assesses retrospective behaviors. Retrospective scores range from 11-55 and Prospective scores range from 11-55. Total scores for overall self-regulation range from 22-110. A higher score indicates higher levels of PA self-regulation. Results reported reflect mean changes from pre to post-intervention week.

Outcome measures

Measure	Intervention Group n=13 Participants Participants receive the allocated intervention to help manage gestational weight gain that includes education on weight regulation, healthy eating, physical activity, and goal setting. Intervention group: During the intervention, all participants will start out at the Baseline level. The baseline level will last 2 weeks and there will be an assessment to determine weight gain over those 2 weeks. If weight gain has succeeded the recommended amount, participants will be adapted up to a new level of intervention that includes education on GWG, healthy eating and physical activity. After every 4 weeks, an assessment will be performed and adaptations up will be made if necessary. Adaptations include addition of exercise sessions, healthy eating recipe demonstrations, and meal replacements. Participants will weigh themselves daily, wear an activity monitor, record their diet, and complete paper and online surveys.	Control Group n=14 Participants Participants do not receive the allocated intervention but self-monitor their behaviors, complete study tasks and receive prenatal care as normal. Control group: Participants will follow the same self-monitoring/assessment schedule but will not receive the GWG, healthy eating, and physical activity education or adaptations.
Self-regulation of Physical Activity Physical Activity Prospective Self-Regulation	-1.3 score on a scale Interval -5.0 to 2.3	-4.9 score on a scale Interval -8.4 to -1.4
Self-regulation of Physical Activity Physical Activity Retrospective Self-Regulation	5.6 score on a scale Interval 1.2 to 10.1	0.3 score on a scale Interval -4.0 to 4.7

SECONDARY outcome

Timeframe: Daily data was collected starting at pre-intervention, through study completion post-intervention. Daily for a total of 6 months. Outcome measure reported at mean change from pre- to post-intervention.

Women will be wearing the UP Jawbone for the entire six week intervention. UP will track how the participants sleep, move and eat. Women will be wearing the UP Jawbone in counterbalance with the Actigraph wGt3X-BTI. The specific outcome measure used from the activity monitor is calories (kcals) burned during physical activity/exercise. Outcome measure reported at mean change from pre- to post-intervention.

Outcome measures

Measure	Intervention Group n=13 Participants Participants receive the allocated intervention to help manage gestational weight gain that includes education on weight regulation, healthy eating, physical activity, and goal setting. Intervention group: During the intervention, all participants will start out at the Baseline level. The baseline level will last 2 weeks and there will be an assessment to determine weight gain over those 2 weeks. If weight gain has succeeded the recommended amount, participants will be adapted up to a new level of intervention that includes education on GWG, healthy eating and physical activity. After every 4 weeks, an assessment will be performed and adaptations up will be made if necessary. Adaptations include addition of exercise sessions, healthy eating recipe demonstrations, and meal replacements. Participants will weigh themselves daily, wear an activity monitor, record their diet, and complete paper and online surveys.	Control Group n=14 Participants Participants do not receive the allocated intervention but self-monitor their behaviors, complete study tasks and receive prenatal care as normal. Control group: Participants will follow the same self-monitoring/assessment schedule but will not receive the GWG, healthy eating, and physical activity education or adaptations.
Objective Activity Monitor UP Jawbone	34.9 calories per day Interval -245.6 to 315.4	-78.9 calories per day Interval -273.5 to 115.7

SECONDARY outcome

Timeframe: Daily energy intake was estimated starting at pre-intervention through post-intervention. Each day for 6 months. Outcome measure reported as mean change of energy intake calories from pre to post-intervention.

Estimated energy intake (kcals) from physical activity (kcals) and weight (GWG). Outcome measure reported as mean change of energy intake calories from pre to post-intervention.

Outcome measures

Measure	Intervention Group n=13 Participants Participants receive the allocated intervention to help manage gestational weight gain that includes education on weight regulation, healthy eating, physical activity, and goal setting. Intervention group: During the intervention, all participants will start out at the Baseline level. The baseline level will last 2 weeks and there will be an assessment to determine weight gain over those 2 weeks. If weight gain has succeeded the recommended amount, participants will be adapted up to a new level of intervention that includes education on GWG, healthy eating and physical activity. After every 4 weeks, an assessment will be performed and adaptations up will be made if necessary. Adaptations include addition of exercise sessions, healthy eating recipe demonstrations, and meal replacements. Participants will weigh themselves daily, wear an activity monitor, record their diet, and complete paper and online surveys.	Control Group n=14 Participants Participants do not receive the allocated intervention but self-monitor their behaviors, complete study tasks and receive prenatal care as normal. Control group: Participants will follow the same self-monitoring/assessment schedule but will not receive the GWG, healthy eating, and physical activity education or adaptations.
Energy Intake	410.2 calories per day Interval 32.4 to 787.9	1134.8 calories per day Interval 697.3 to 1572.3

SECONDARY outcome

Timeframe: Data was collected 3 days a week, each week from pre-intervention through post-intervention. A total of 72 days over 6 months. Outcome measure reported as mean change of energy intake calories from pre-intervention week to post-intervention week.

MyFitness Pal: Web-based and smartphone app dietary intake tracker. Women tracked their diets every day for 6 months and every day for one week at their 6 week postpartum period. Energy intake or calories (kcal) consumed each day were measured. Outcome measure reported as mean change of energy intake calories from pre to post-intervention.

Outcome measures

Measure	Intervention Group n=9 Participants Participants receive the allocated intervention to help manage gestational weight gain that includes education on weight regulation, healthy eating, physical activity, and goal setting. Intervention group: During the intervention, all participants will start out at the Baseline level. The baseline level will last 2 weeks and there will be an assessment to determine weight gain over those 2 weeks. If weight gain has succeeded the recommended amount, participants will be adapted up to a new level of intervention that includes education on GWG, healthy eating and physical activity. After every 4 weeks, an assessment will be performed and adaptations up will be made if necessary. Adaptations include addition of exercise sessions, healthy eating recipe demonstrations, and meal replacements. Participants will weigh themselves daily, wear an activity monitor, record their diet, and complete paper and online surveys.	Control Group n=10 Participants Participants do not receive the allocated intervention but self-monitor their behaviors, complete study tasks and receive prenatal care as normal. Control group: Participants will follow the same self-monitoring/assessment schedule but will not receive the GWG, healthy eating, and physical activity education or adaptations.
MyFitnessPal	1541.5 calories per day Standard Deviation 372.9	1402.2 calories per day Standard Deviation 413.3

SECONDARY outcome

Timeframe: Data was collected monthly starting at pre-intervention, through post-intervention - Pre-intervention, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, post-intervention.

The Three Factor Eating Questionnaire is a 51-item questionnaire to measure three dimensions of human eating behavior: 1) dietary restraint, or cognitive control of eating behavior, 2) dietary disinhibition, or disinhibition of cognitive control of eating, and 3) susceptibility to hunger. The investigators are only using 18 items of the revised TFEQ. These items are known as TFEQ-R18 as reported in (de Lauzon et al., 2004). The TFEQ is examined by subscale scores and not by a total score. Subscale scores for the cognitive restraint scale range from 3-12; higher scores indicate higher levels of cognitive restraint of eating. Uncontrolled eating scale range from 9-36; higher scores indicate higher levels of uncontrolled eating behaviors. Emotional eating scale range from 6-24; higher scores indicate higher levels of emotional eating behaviors. Outcome measure results are reported as the score during the post-intervention week.

Outcome measures

Measure	Intervention Group n=11 Participants Participants receive the allocated intervention to help manage gestational weight gain that includes education on weight regulation, healthy eating, physical activity, and goal setting. Intervention group: During the intervention, all participants will start out at the Baseline level. The baseline level will last 2 weeks and there will be an assessment to determine weight gain over those 2 weeks. If weight gain has succeeded the recommended amount, participants will be adapted up to a new level of intervention that includes education on GWG, healthy eating and physical activity. After every 4 weeks, an assessment will be performed and adaptations up will be made if necessary. Adaptations include addition of exercise sessions, healthy eating recipe demonstrations, and meal replacements. Participants will weigh themselves daily, wear an activity monitor, record their diet, and complete paper and online surveys.	Control Group n=12 Participants Participants do not receive the allocated intervention but self-monitor their behaviors, complete study tasks and receive prenatal care as normal. Control group: Participants will follow the same self-monitoring/assessment schedule but will not receive the GWG, healthy eating, and physical activity education or adaptations.
Three Factor Eating Questionnaire Cognitive Restraint	7.3 score on a scale Standard Deviation 1.7	7.5 score on a scale Standard Deviation 1.9
Three Factor Eating Questionnaire Emotional Eating	11.2 score on a scale Standard Deviation 4.5	12.3 score on a scale Standard Deviation 3.98
Three Factor Eating Questionnaire Uncontrolled Eating	19.1 score on a scale Standard Deviation 6.8	17.0 score on a scale Standard Deviation 3.2

SECONDARY outcome

Timeframe: Data was collected monthly starting at pre-intervention, through post-intervention - Pre-intervention, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, post-intervention.

The Leisure-Time Exercise Questionnaire (LTEQ) is a 3 item questionnaire to measure the amount and intensity of exercise a person engages in during a one week period. Reported scores are multiplied by 15 to get total min/week for each type and then adding those values together to total min of weekly exercise. Higher scores reflect more minutes of physical activity. Results reported reflect mean changes from pre- to post-intervention.

Outcome measures

Measure	Intervention Group n=10 Participants Participants receive the allocated intervention to help manage gestational weight gain that includes education on weight regulation, healthy eating, physical activity, and goal setting. Intervention group: During the intervention, all participants will start out at the Baseline level. The baseline level will last 2 weeks and there will be an assessment to determine weight gain over those 2 weeks. If weight gain has succeeded the recommended amount, participants will be adapted up to a new level of intervention that includes education on GWG, healthy eating and physical activity. After every 4 weeks, an assessment will be performed and adaptations up will be made if necessary. Adaptations include addition of exercise sessions, healthy eating recipe demonstrations, and meal replacements. Participants will weigh themselves daily, wear an activity monitor, record their diet, and complete paper and online surveys.	Control Group n=10 Participants Participants do not receive the allocated intervention but self-monitor their behaviors, complete study tasks and receive prenatal care as normal. Control group: Participants will follow the same self-monitoring/assessment schedule but will not receive the GWG, healthy eating, and physical activity education or adaptations.
Leisure Time Exercise Questionnaire	315 minutes/week Standard Deviation 399.0	184.5 minutes/week Standard Deviation 272.2

SECONDARY outcome

Timeframe: Data was collected monthly starting at pre-intervention, through post-intervention - Pre-intervention, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, post-intervention.

Pittsburgh Sleep Quality Index: The Pittsburgh Sleep Quality Index (PSQI) is an 18-item measure developed by Smyth (2003) to measure the quality and patterns of sleep in older adults. It differentiates "poor" from "good" sleep by measuring seven areas: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication and daytime dysfunction over the last month. Scores can range from 0-21. An overall sleep quality score greater than or equal to 5 reflects poor sleep quality. The outcome reported is overall sleep quality. Results reported reflect mean at post-intervention.

Outcome measures

Measure	Intervention Group n=9 Participants Participants receive the allocated intervention to help manage gestational weight gain that includes education on weight regulation, healthy eating, physical activity, and goal setting. Intervention group: During the intervention, all participants will start out at the Baseline level. The baseline level will last 2 weeks and there will be an assessment to determine weight gain over those 2 weeks. If weight gain has succeeded the recommended amount, participants will be adapted up to a new level of intervention that includes education on GWG, healthy eating and physical activity. After every 4 weeks, an assessment will be performed and adaptations up will be made if necessary. Adaptations include addition of exercise sessions, healthy eating recipe demonstrations, and meal replacements. Participants will weigh themselves daily, wear an activity monitor, record their diet, and complete paper and online surveys.	Control Group n=12 Participants Participants do not receive the allocated intervention but self-monitor their behaviors, complete study tasks and receive prenatal care as normal. Control group: Participants will follow the same self-monitoring/assessment schedule but will not receive the GWG, healthy eating, and physical activity education or adaptations.
Pittsburgh Sleep Quality Index	7.0 score on a scale Standard Deviation 3.6	6.1 score on a scale Standard Deviation 2.9

SECONDARY outcome

Timeframe: Data was collected each day starting at pre-intervention, through post-intervention - a total of 6 months of daily data collection.

UP Jawbone activity monitor: women wear the monitor during the night and measures sleep duration. This outcome reports mean nighttime sleep duration over the entire study duration.

Outcome measures

Measure	Intervention Group n=13 Participants Participants receive the allocated intervention to help manage gestational weight gain that includes education on weight regulation, healthy eating, physical activity, and goal setting. Intervention group: During the intervention, all participants will start out at the Baseline level. The baseline level will last 2 weeks and there will be an assessment to determine weight gain over those 2 weeks. If weight gain has succeeded the recommended amount, participants will be adapted up to a new level of intervention that includes education on GWG, healthy eating and physical activity. After every 4 weeks, an assessment will be performed and adaptations up will be made if necessary. Adaptations include addition of exercise sessions, healthy eating recipe demonstrations, and meal replacements. Participants will weigh themselves daily, wear an activity monitor, record their diet, and complete paper and online surveys.	Control Group n=14 Participants Participants do not receive the allocated intervention but self-monitor their behaviors, complete study tasks and receive prenatal care as normal. Control group: Participants will follow the same self-monitoring/assessment schedule but will not receive the GWG, healthy eating, and physical activity education or adaptations.
Sleep Behaviors (Activity Monitor) - Nighttime Sleep Duration	414.5 minutes Standard Deviation 45.2	451.3 minutes Standard Deviation 74.2

SECONDARY outcome

Timeframe: Each month - Month 1, Month 2, Month 3, Month 4, Month 5, and Month 6. Data reported is the sum of all flagged ultrasounds over the study duration.

Ultrasounds are conducted each month to measure fetal growth. Ultrasounds were completed for fetal growth measures as well to ensure adequate growth for those in the study. If there were any flags for growth restriction concerns, participant's physicians were alerted. These ultrasounds were used as safety checks and to ensure proper fetal growth. No group analyses were conducted nor were there any comparisons between groups. Data reported is the sum of all flagged ultrasounds over the study duration.

Outcome measures

Measure	Intervention Group n=13 Participants Participants receive the allocated intervention to help manage gestational weight gain that includes education on weight regulation, healthy eating, physical activity, and goal setting. Intervention group: During the intervention, all participants will start out at the Baseline level. The baseline level will last 2 weeks and there will be an assessment to determine weight gain over those 2 weeks. If weight gain has succeeded the recommended amount, participants will be adapted up to a new level of intervention that includes education on GWG, healthy eating and physical activity. After every 4 weeks, an assessment will be performed and adaptations up will be made if necessary. Adaptations include addition of exercise sessions, healthy eating recipe demonstrations, and meal replacements. Participants will weigh themselves daily, wear an activity monitor, record their diet, and complete paper and online surveys.	Control Group n=14 Participants Participants do not receive the allocated intervention but self-monitor their behaviors, complete study tasks and receive prenatal care as normal. Control group: Participants will follow the same self-monitoring/assessment schedule but will not receive the GWG, healthy eating, and physical activity education or adaptations.
Fetal Measure: Ultrasounds [Fetal Growth]	8 ultrasounds	0 ultrasounds

SECONDARY outcome

Timeframe: Assessed at time of birth - data abstracted at 6-week postpartum session.

The infant's birth weight will be obtained through medical records or self-report from mother.

Outcome measures

Measure	Intervention Group n=13 Participants Participants receive the allocated intervention to help manage gestational weight gain that includes education on weight regulation, healthy eating, physical activity, and goal setting. Intervention group: During the intervention, all participants will start out at the Baseline level. The baseline level will last 2 weeks and there will be an assessment to determine weight gain over those 2 weeks. If weight gain has succeeded the recommended amount, participants will be adapted up to a new level of intervention that includes education on GWG, healthy eating and physical activity. After every 4 weeks, an assessment will be performed and adaptations up will be made if necessary. Adaptations include addition of exercise sessions, healthy eating recipe demonstrations, and meal replacements. Participants will weigh themselves daily, wear an activity monitor, record their diet, and complete paper and online surveys.	Control Group n=13 Participants Participants do not receive the allocated intervention but self-monitor their behaviors, complete study tasks and receive prenatal care as normal. Control group: Participants will follow the same self-monitoring/assessment schedule but will not receive the GWG, healthy eating, and physical activity education or adaptations.
Infant Birthweight	3379.7 grams Standard Deviation 628.5	3266.4 grams Standard Deviation 672.6

SECONDARY outcome

Timeframe: Assessed at time of birth - data abstracted at 6-week postpartum session.

The infant's birth length will be obtained through medical records or self-report from mother

Outcome measures

Measure	Intervention Group n=7 Participants Participants receive the allocated intervention to help manage gestational weight gain that includes education on weight regulation, healthy eating, physical activity, and goal setting. Intervention group: During the intervention, all participants will start out at the Baseline level. The baseline level will last 2 weeks and there will be an assessment to determine weight gain over those 2 weeks. If weight gain has succeeded the recommended amount, participants will be adapted up to a new level of intervention that includes education on GWG, healthy eating and physical activity. After every 4 weeks, an assessment will be performed and adaptations up will be made if necessary. Adaptations include addition of exercise sessions, healthy eating recipe demonstrations, and meal replacements. Participants will weigh themselves daily, wear an activity monitor, record their diet, and complete paper and online surveys.	Control Group n=7 Participants Participants do not receive the allocated intervention but self-monitor their behaviors, complete study tasks and receive prenatal care as normal. Control group: Participants will follow the same self-monitoring/assessment schedule but will not receive the GWG, healthy eating, and physical activity education or adaptations.
Infant Length	43.9 centimeters Standard Deviation 1.9	52.5 centimeters Standard Deviation 2.6

SECONDARY outcome

Timeframe: Data was collected weekly from pre-intervention to post-intervention - Pre-intervention, week 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 ,15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, post-intervention.

The Breezing Device: An indirect calorimetry analyzer that measures the rate of oxygen consumption and carbon dioxide production and determines how much energy the body is burning due to the metabolism of nutrients (named Resting Energy Expenditure, REE), and the type of nutrients the body uses to produce energy (Energy source = respiratory quotient, RQ). Developed at Arizona State University. The Breezing is a cellphone-size, battery operated, portable technology that syncs with smartphones. This tracker takes a traditional laboratory-based measurement and makes it faster, more affordable and mobile. Breezing has a 99.8% correlation with the gold standard method, Douglas Bag. Outcome measure is reported as an average over the entire study period.

Outcome measures

Measure	Intervention Group n=8 Participants Participants receive the allocated intervention to help manage gestational weight gain that includes education on weight regulation, healthy eating, physical activity, and goal setting. Intervention group: During the intervention, all participants will start out at the Baseline level. The baseline level will last 2 weeks and there will be an assessment to determine weight gain over those 2 weeks. If weight gain has succeeded the recommended amount, participants will be adapted up to a new level of intervention that includes education on GWG, healthy eating and physical activity. After every 4 weeks, an assessment will be performed and adaptations up will be made if necessary. Adaptations include addition of exercise sessions, healthy eating recipe demonstrations, and meal replacements. Participants will weigh themselves daily, wear an activity monitor, record their diet, and complete paper and online surveys.	Control Group n=12 Participants Participants do not receive the allocated intervention but self-monitor their behaviors, complete study tasks and receive prenatal care as normal. Control group: Participants will follow the same self-monitoring/assessment schedule but will not receive the GWG, healthy eating, and physical activity education or adaptations.
Resting Metabolic Rate	1861.12 kcals/day Standard Deviation 297.46	1867.10 kcals/day Standard Deviation 324.35

SECONDARY outcome

Timeframe: Data was collected monthly starting at pre-intervention, through study post-intervention - Pre-intervention, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, and post-intervention. Outcome measure is reported as the score at post-intervention.

The Body Area Satisfaction Scale (BASS) measure is a 9-item subscale originating from the Multidimensional Body-Self Relations Questionnaire (MBSRQ), which is a 69-item self-report inventory for the assessment of self-attitudinal aspects of the construct of body-image. The BASS assesses one's personal satisfaction with body parts such as arms, legs, and face in which participants rate their degree of body satisfaction with each specified body party from 1 (very dissatisfied) to 5 (very satisfied). The first 8 of the 9 items are added together for a total score. Scores range from 8-40. A higher score indicates higher body satisfaction. Outcome measure is reported as the score at post-intervention.

Outcome measures

Measure	Intervention Group n=11 Participants Participants receive the allocated intervention to help manage gestational weight gain that includes education on weight regulation, healthy eating, physical activity, and goal setting. Intervention group: During the intervention, all participants will start out at the Baseline level. The baseline level will last 2 weeks and there will be an assessment to determine weight gain over those 2 weeks. If weight gain has succeeded the recommended amount, participants will be adapted up to a new level of intervention that includes education on GWG, healthy eating and physical activity. After every 4 weeks, an assessment will be performed and adaptations up will be made if necessary. Adaptations include addition of exercise sessions, healthy eating recipe demonstrations, and meal replacements. Participants will weigh themselves daily, wear an activity monitor, record their diet, and complete paper and online surveys.	Control Group n=12 Participants Participants do not receive the allocated intervention but self-monitor their behaviors, complete study tasks and receive prenatal care as normal. Control group: Participants will follow the same self-monitoring/assessment schedule but will not receive the GWG, healthy eating, and physical activity education or adaptations.
Body Area Satisfaction Scale	25.2 score on a scale Standard Deviation 3.6	23.5 score on a scale Standard Deviation 4.6

SECONDARY outcome

Timeframe: Data was collected monthly starting at pre-intervention, through study post-intervention - Pre-intervention, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, and post-intervention. Results are the mean scores at the post-intervention time period.

Center for Epidemiological Studies Depression Scale (CESD): Measures current levels of depressive symptomology. A cut off score of 16 is used to determine case status (depressed versus not depressed). A higher score (above 16) represents depressive symptomology. A total CES-D score can be calculated [Total CES-D Score = sum (items 1-20)]. Scores range from 0-60. Outcome reported is the mean scores at the post-intervention time period.

Outcome measures

Measure	Intervention Group n=12 Participants Participants receive the allocated intervention to help manage gestational weight gain that includes education on weight regulation, healthy eating, physical activity, and goal setting. Intervention group: During the intervention, all participants will start out at the Baseline level. The baseline level will last 2 weeks and there will be an assessment to determine weight gain over those 2 weeks. If weight gain has succeeded the recommended amount, participants will be adapted up to a new level of intervention that includes education on GWG, healthy eating and physical activity. After every 4 weeks, an assessment will be performed and adaptations up will be made if necessary. Adaptations include addition of exercise sessions, healthy eating recipe demonstrations, and meal replacements. Participants will weigh themselves daily, wear an activity monitor, record their diet, and complete paper and online surveys.	Control Group n=14 Participants Participants do not receive the allocated intervention but self-monitor their behaviors, complete study tasks and receive prenatal care as normal. Control group: Participants will follow the same self-monitoring/assessment schedule but will not receive the GWG, healthy eating, and physical activity education or adaptations.
Center for Epidemiological Studies Depression Scale	10.6 score on a scale Standard Deviation 8.0	8.1 score on a scale Standard Deviation 5.1

SECONDARY outcome

Timeframe: Data was collected monthly starting at pre-intervention through post-intervention: Pre-intervention, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, and Post-intervention. Results reported reflect mean scores at the post-intervention time period.

The State-Trait Anxiety Inventory (STAI) is a 20-item questionnaire to measure state and trait anxiety. The State version of the STAI is being used for the current study. This scale consists of twenty items that evaluate how respondents feel "right now, at this moment." In responding to the STAI State-Anxiety scale, participants choose the response statement that best describes the intensity of their feelings: (1) not at all; (2) somewhat; (3) moderately so; (4) very much so. The state version of the STAI can also be used to evaluate how someone felt at a particular time in the recent past and how they anticipated to feel either in a specific situation that is likely to be encountered in the future or in a variety of hypothetical situations. Scores can range: 20-80. A total score is used to determine anxiety. A higher score indicates higher anxiety. Outcome reported is the mean scores at the post-intervention time period.

Outcome measures

Measure	Intervention Group n=11 Participants Participants receive the allocated intervention to help manage gestational weight gain that includes education on weight regulation, healthy eating, physical activity, and goal setting. Intervention group: During the intervention, all participants will start out at the Baseline level. The baseline level will last 2 weeks and there will be an assessment to determine weight gain over those 2 weeks. If weight gain has succeeded the recommended amount, participants will be adapted up to a new level of intervention that includes education on GWG, healthy eating and physical activity. After every 4 weeks, an assessment will be performed and adaptations up will be made if necessary. Adaptations include addition of exercise sessions, healthy eating recipe demonstrations, and meal replacements. Participants will weigh themselves daily, wear an activity monitor, record their diet, and complete paper and online surveys.	Control Group n=12 Participants Participants do not receive the allocated intervention but self-monitor their behaviors, complete study tasks and receive prenatal care as normal. Control group: Participants will follow the same self-monitoring/assessment schedule but will not receive the GWG, healthy eating, and physical activity education or adaptations.
State-Trait Anxiety Inventory	36.1 score on a scale Standard Deviation 13.3	29.0 score on a scale Standard Deviation 9.7

SECONDARY outcome

Timeframe: Assessed weekly at pre-intervention week, week 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, and post-intervention. Post-intervention mean scores reported.

The Perceived Stress Scale (PSS) is a 10-item scale developed by Cohen (1988) that measures the degree to which situations in one's life are appraised as stressful. The PSS was designed for use with community samples with at least a junior high-school education. The 14 items are easy to understand and the response alternatives (never, almost never, neutral, sometimes, fairly often, very often) are simple to grasp. The questions are quite general in nature and hence relatively free of content specific to any sub-population group. Scores range from 0-40. A higher score indicates higher levels of perceived stress.

Outcome measures

Measure	Intervention Group n=12 Participants Participants receive the allocated intervention to help manage gestational weight gain that includes education on weight regulation, healthy eating, physical activity, and goal setting. Intervention group: During the intervention, all participants will start out at the Baseline level. The baseline level will last 2 weeks and there will be an assessment to determine weight gain over those 2 weeks. If weight gain has succeeded the recommended amount, participants will be adapted up to a new level of intervention that includes education on GWG, healthy eating and physical activity. After every 4 weeks, an assessment will be performed and adaptations up will be made if necessary. Adaptations include addition of exercise sessions, healthy eating recipe demonstrations, and meal replacements. Participants will weigh themselves daily, wear an activity monitor, record their diet, and complete paper and online surveys.	Control Group n=14 Participants Participants do not receive the allocated intervention but self-monitor their behaviors, complete study tasks and receive prenatal care as normal. Control group: Participants will follow the same self-monitoring/assessment schedule but will not receive the GWG, healthy eating, and physical activity education or adaptations.
Perceived Stress Scale	25 score on a scale Standard Deviation 8.6	23.2 score on a scale Standard Deviation 7.2

SECONDARY outcome

Timeframe: Data was collected each day starting at pre-intervention, through post-intervention - a total of 6 months of daily data collection.

UP Jawbone activity monitor: women wear the monitor during the night. The monitor measures number of awakenings. This outcome reports mean nighttime awakenings per night over the entire study duration (pre- to post-intervention).

Outcome measures

Measure	Intervention Group n=13 Participants Participants receive the allocated intervention to help manage gestational weight gain that includes education on weight regulation, healthy eating, physical activity, and goal setting. Intervention group: During the intervention, all participants will start out at the Baseline level. The baseline level will last 2 weeks and there will be an assessment to determine weight gain over those 2 weeks. If weight gain has succeeded the recommended amount, participants will be adapted up to a new level of intervention that includes education on GWG, healthy eating and physical activity. After every 4 weeks, an assessment will be performed and adaptations up will be made if necessary. Adaptations include addition of exercise sessions, healthy eating recipe demonstrations, and meal replacements. Participants will weigh themselves daily, wear an activity monitor, record their diet, and complete paper and online surveys.	Control Group n=14 Participants Participants do not receive the allocated intervention but self-monitor their behaviors, complete study tasks and receive prenatal care as normal. Control group: Participants will follow the same self-monitoring/assessment schedule but will not receive the GWG, healthy eating, and physical activity education or adaptations.
Sleep Behaviors (Activity Monitor) - Nighttime Awakenings	1.8 nighttime awakenings Standard Deviation .7	1.7 nighttime awakenings Standard Deviation .8

Adverse Events

Intervention Group

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Intervention Group n=15 participants at risk Participants receive the allocated intervention to help manage gestational weight gain that includes education on weight regulation, healthy eating, physical activity, and goal setting. Intervention group: During the intervention, all participants will start out at the Baseline level. The baseline level will last 2 weeks and there will be an assessment to determine weight gain over those 2 weeks. If weight gain has succeeded the recommended amount, participants will be adapted up to a new level of intervention that includes education on GWG, healthy eating and physical activity. After every 4 weeks, an assessment will be performed and adaptations up will be made if necessary. Adaptations include addition of exercise sessions, healthy eating recipe demonstrations, and meal replacements. Participants will weigh themselves daily, wear an activity monitor, record their diet, and complete paper and online surveys.	Control Group n=16 participants at risk Participants do not receive the allocated intervention but self-monitor their behaviors, complete study tasks and receive prenatal care as normal. Control group: Participants will follow the same self-monitoring/assessment schedule but will not receive the GWG, healthy eating, and physical activity education or adaptations.
Pregnancy, puerperium and perinatal conditions Fetal Growth and Abnormalities	53.3% 8/15 • Number of events 8 • Tracking of adverse events was done over a 6 month period. Adverse events were tracked/collected if any woman experienced any obstetric issues with the physical activity sessions or healthy eating demonstrations. Our protocol stated that ALL physical activity sessions and healthy eating demonstrations were performed and monitored by a certified prenatal exercise specialist or a registered dietician and all sessions were monitored by a Penn State employed nurse and a member of the study team. Any events were immediately reported to the PI and the IRB.	0.00% 0/16 • Tracking of adverse events was done over a 6 month period. Adverse events were tracked/collected if any woman experienced any obstetric issues with the physical activity sessions or healthy eating demonstrations. Our protocol stated that ALL physical activity sessions and healthy eating demonstrations were performed and monitored by a certified prenatal exercise specialist or a registered dietician and all sessions were monitored by a Penn State employed nurse and a member of the study team. Any events were immediately reported to the PI and the IRB.
Psychiatric disorders Depressive Symptoms	6.7% 1/15 • Number of events 1 • Tracking of adverse events was done over a 6 month period. Adverse events were tracked/collected if any woman experienced any obstetric issues with the physical activity sessions or healthy eating demonstrations. Our protocol stated that ALL physical activity sessions and healthy eating demonstrations were performed and monitored by a certified prenatal exercise specialist or a registered dietician and all sessions were monitored by a Penn State employed nurse and a member of the study team. Any events were immediately reported to the PI and the IRB.	18.8% 3/16 • Number of events 3 • Tracking of adverse events was done over a 6 month period. Adverse events were tracked/collected if any woman experienced any obstetric issues with the physical activity sessions or healthy eating demonstrations. Our protocol stated that ALL physical activity sessions and healthy eating demonstrations were performed and monitored by a certified prenatal exercise specialist or a registered dietician and all sessions were monitored by a Penn State employed nurse and a member of the study team. Any events were immediately reported to the PI and the IRB.
Metabolism and nutrition disorders Gestational Diabetes	6.7% 1/15 • Number of events 1 • Tracking of adverse events was done over a 6 month period. Adverse events were tracked/collected if any woman experienced any obstetric issues with the physical activity sessions or healthy eating demonstrations. Our protocol stated that ALL physical activity sessions and healthy eating demonstrations were performed and monitored by a certified prenatal exercise specialist or a registered dietician and all sessions were monitored by a Penn State employed nurse and a member of the study team. Any events were immediately reported to the PI and the IRB.	18.8% 3/16 • Number of events 3 • Tracking of adverse events was done over a 6 month period. Adverse events were tracked/collected if any woman experienced any obstetric issues with the physical activity sessions or healthy eating demonstrations. Our protocol stated that ALL physical activity sessions and healthy eating demonstrations were performed and monitored by a certified prenatal exercise specialist or a registered dietician and all sessions were monitored by a Penn State employed nurse and a member of the study team. Any events were immediately reported to the PI and the IRB.
Blood and lymphatic system disorders Maternal Blood Draw and Anemia	13.3% 2/15 • Number of events 2 • Tracking of adverse events was done over a 6 month period. Adverse events were tracked/collected if any woman experienced any obstetric issues with the physical activity sessions or healthy eating demonstrations. Our protocol stated that ALL physical activity sessions and healthy eating demonstrations were performed and monitored by a certified prenatal exercise specialist or a registered dietician and all sessions were monitored by a Penn State employed nurse and a member of the study team. Any events were immediately reported to the PI and the IRB.	6.2% 1/16 • Number of events 1 • Tracking of adverse events was done over a 6 month period. Adverse events were tracked/collected if any woman experienced any obstetric issues with the physical activity sessions or healthy eating demonstrations. Our protocol stated that ALL physical activity sessions and healthy eating demonstrations were performed and monitored by a certified prenatal exercise specialist or a registered dietician and all sessions were monitored by a Penn State employed nurse and a member of the study team. Any events were immediately reported to the PI and the IRB.

Additional Information

Dr. Abigail Pauley

Pennsylvania State University

Phone: 814-863-7354

Email: amp34@psu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place