Trial Outcomes & Findings for My Baby My Move A Community Wellness Intervention (NCT NCT04294095)

NCT ID: NCT04294095

Last Updated: 2023-03-21

Results Overview

Average weight

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 68 participants
• Primary outcome timeframe: 12 week post-baseline
• Results posted on: 2023-03-21

Participant Flow

68 participants were consented - 18 dropped out prior to randomization due to physician request, no longer interested A total of 50 participants were randomized of which 49 completed all assessments.

Participant milestones

Measure	Intervention During the first four weeks of the MBMM+ program, participants will receive electronic informational handouts covering topics on weight management as well as the benefits and safety concerns related to prenatal physical activity. Starting week 5 of the 12-week intervention, participants will attend two in-person, group physical activity sessions per week with each session lasting approximately 60 minutes and will be held at a local community center located close to the recruitment clinics. Sessions will be held on weekday evenings and weekend mornings as these times were preferred by pregnant women. Each session will include both didactic and experiential components to increase knowledge and skill building. Please note that in-person sessions were moved to online platform for the entire trial due to covid. My Baby My Move +: This is a community-based, peer-led 12-week wellness intervention to decrease excessive gestational weight gain.	Control Electronic materials related to various prenatal topics including preparation for birth, birthing options, and responsive parenting will be distributed twice a week for the first 4-weeks of the program. Starting week 5 of the 12-week intervention, participants will attend two in-person, group sessions per week with each session lasting approximately 60 minutes and will be held at a local community center located close to the recruitment clinics. Control: This is a 12-week basic prenatal education class. Please note that in-person sessions were moved to online platform for the entire trial due to covid.
Overall Study STARTED	26	24
Overall Study COMPLETED	25	24
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Intervention During the first four weeks of the MBMM+ program, participants will receive electronic informational handouts covering topics on weight management as well as the benefits and safety concerns related to prenatal physical activity. Starting week 5 of the 12-week intervention, participants will attend two in-person, group physical activity sessions per week with each session lasting approximately 60 minutes and will be held at a local community center located close to the recruitment clinics. Sessions will be held on weekday evenings and weekend mornings as these times were preferred by pregnant women. Each session will include both didactic and experiential components to increase knowledge and skill building. Please note that in-person sessions were moved to online platform for the entire trial due to covid. My Baby My Move +: This is a community-based, peer-led 12-week wellness intervention to decrease excessive gestational weight gain.	Control Electronic materials related to various prenatal topics including preparation for birth, birthing options, and responsive parenting will be distributed twice a week for the first 4-weeks of the program. Starting week 5 of the 12-week intervention, participants will attend two in-person, group sessions per week with each session lasting approximately 60 minutes and will be held at a local community center located close to the recruitment clinics. Control: This is a 12-week basic prenatal education class. Please note that in-person sessions were moved to online platform for the entire trial due to covid.
Overall Study Adverse Event	1	0

Baseline Characteristics

My Baby My Move A Community Wellness Intervention

Baseline characteristics by cohort

Measure	Intervention n=25 Participants During the first four weeks of the MBMM+ program, participants will receive electronic informational handouts covering topics on weight management as well as the benefits and safety concerns related to prenatal physical activity. Starting week 5 of the 12-week intervention, participants will attend two in-person, group physical activity sessions per week with each session lasting approximately 60 minutes and will be held at a local community center located close to the recruitment clinics. Sessions will be held on weekday evenings and weekend mornings as these times were preferred by pregnant women. Each session will include both didactic and experiential components to increase knowledge and skill building. Please note that in-person sessions were moved to online platform for the entire trial due to covid. My Baby My Move +: This is a community-based, peer-led 12-week wellness intervention to decrease excessive gestational weight gain.	Control n=24 Participants Electronic materials related to various prenatal topics including preparation for birth, birthing options, and responsive parenting will be distributed twice a week for the first 4-weeks of the program. Starting week 5 of the 12-week intervention, participants will attend two in-person, group sessions per week with each session lasting approximately 60 minutes and will be held at a local community center located close to the recruitment clinics. Control: This is a 12-week basic prenatal education class. Please note that in-person sessions were moved to online platform for the entire trial due to covid.	Total n=49 Participants Total of all reporting groups
Age, Continuous	32.1 years STANDARD_DEVIATION 4.87 • n=5 Participants	31.5 years STANDARD_DEVIATION 4.3 • n=7 Participants	31.8 years STANDARD_DEVIATION 4.5 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	24 Participants n=7 Participants	49 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	7 participants n=5 Participants	4 participants n=7 Participants	11 participants n=5 Participants
Race/Ethnicity, Customized nonHispanic	18 participants n=5 Participants	20 participants n=7 Participants	38 participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	24 participants n=7 Participants	49 participants n=5 Participants
Weight Underweight	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Weight Normal Weight	11 Participants n=5 Participants	15 Participants n=7 Participants	26 Participants n=5 Participants
Weight Overweight	8 Participants n=5 Participants	3 Participants n=7 Participants	11 Participants n=5 Participants
Weight Obese	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 week post-baseline

Population: Average Weight of pregnant women for intervention versus control at 12 weeks post-baseline

Average weight

Outcome measures

Measure	Intervention n=25 Participants During the first four weeks of the MBMM+ program, participants will receive electronic informational handouts covering topics on weight management as well as the benefits and safety concerns related to prenatal physical activity. Starting week 5 of the 12-week intervention, participants will attend two in-person, group physical activity sessions per week with each session lasting approximately 60 minutes and will be held at a local community center located close to the recruitment clinics. Sessions will be held on weekday evenings and weekend mornings as these times were preferred by pregnant women. Each session will include both didactic and experiential components to increase knowledge and skill building. My Baby My Move +: This is a community-based, peer-led 12-week wellness intervention to decrease excessive gestational weight gain.	Control n=24 Participants Electronic materials related to various prenatal topics including preparation for birth, birthing options, and responsive parenting will be distributed twice a week for the first 4-weeks of the program. Starting week 5 of the 12-week intervention, participants will attend two in-person, group sessions per week with each session lasting approximately 60 minutes and will be held at a local community center located close to the recruitment clinics. Control: This is a 12-week basic prenatal education class.
Weight	162.9 pounds Standard Deviation 29.9	162.3 pounds Standard Deviation 37.6

SECONDARY outcome

Timeframe: 12 weeks post-baseline

Population: Depression scores at 12 wks post baseline for intervention vs control

Edinburgh Postnatal Depression Scale (EPDS); scale: 1-30 with higher score indicating higher depression

Outcome measures

Measure	Intervention n=25 Participants During the first four weeks of the MBMM+ program, participants will receive electronic informational handouts covering topics on weight management as well as the benefits and safety concerns related to prenatal physical activity. Starting week 5 of the 12-week intervention, participants will attend two in-person, group physical activity sessions per week with each session lasting approximately 60 minutes and will be held at a local community center located close to the recruitment clinics. Sessions will be held on weekday evenings and weekend mornings as these times were preferred by pregnant women. Each session will include both didactic and experiential components to increase knowledge and skill building. My Baby My Move +: This is a community-based, peer-led 12-week wellness intervention to decrease excessive gestational weight gain.	Control n=24 Participants Electronic materials related to various prenatal topics including preparation for birth, birthing options, and responsive parenting will be distributed twice a week for the first 4-weeks of the program. Starting week 5 of the 12-week intervention, participants will attend two in-person, group sessions per week with each session lasting approximately 60 minutes and will be held at a local community center located close to the recruitment clinics. Control: This is a 12-week basic prenatal education class.
Depression	8.1 units on a scale Standard Deviation 5.4	6.3 units on a scale Standard Deviation 4.4

SECONDARY outcome

Timeframe: 12 weeks post baseline

Population: 12 wk post-baseline anxiety scores for intervention and control

General Anxiety Disorder- 7 scale (GAD-7); 1-7 scale with higher score indicating higher anxiety

Outcome measures

Measure	Intervention n=25 Participants During the first four weeks of the MBMM+ program, participants will receive electronic informational handouts covering topics on weight management as well as the benefits and safety concerns related to prenatal physical activity. Starting week 5 of the 12-week intervention, participants will attend two in-person, group physical activity sessions per week with each session lasting approximately 60 minutes and will be held at a local community center located close to the recruitment clinics. Sessions will be held on weekday evenings and weekend mornings as these times were preferred by pregnant women. Each session will include both didactic and experiential components to increase knowledge and skill building. My Baby My Move +: This is a community-based, peer-led 12-week wellness intervention to decrease excessive gestational weight gain.	Control n=24 Participants Electronic materials related to various prenatal topics including preparation for birth, birthing options, and responsive parenting will be distributed twice a week for the first 4-weeks of the program. Starting week 5 of the 12-week intervention, participants will attend two in-person, group sessions per week with each session lasting approximately 60 minutes and will be held at a local community center located close to the recruitment clinics. Control: This is a 12-week basic prenatal education class.
Anxiety	4.7 units on a scale Standard Deviation 3.1	3.7 units on a scale Standard Deviation 3.2

SECONDARY outcome

Timeframe: 12 weeks Post-baseline

Population: 12 weeks post-baseline assessment of physical activity for intervention and control.

The Godin-Shephard Leisure-Time Physical Activity Questionnaire (LTEQ) assesses when someone engages in mild, moderate, and vigorous exercise for more than 15 minutes within one week. The leisure activity score is calculated using the following formula: leisure activity score = (9 x strenuous activity per week) + (5 x moderate activity per week) + (3 x light activity per week). Strenuous exercise is defined as heart beating rapidly, moderate exercise is defined as not exhausting, and light activity is described as minimal effort. Scores of 14 or less indicate insufficiently active/sedentary, scores of 14-23 indicate moderately active, and scores of more than 24 indicate active.

Outcome measures

Measure	Intervention n=25 Participants During the first four weeks of the MBMM+ program, participants will receive electronic informational handouts covering topics on weight management as well as the benefits and safety concerns related to prenatal physical activity. Starting week 5 of the 12-week intervention, participants will attend two in-person, group physical activity sessions per week with each session lasting approximately 60 minutes and will be held at a local community center located close to the recruitment clinics. Sessions will be held on weekday evenings and weekend mornings as these times were preferred by pregnant women. Each session will include both didactic and experiential components to increase knowledge and skill building. My Baby My Move +: This is a community-based, peer-led 12-week wellness intervention to decrease excessive gestational weight gain.	Control n=24 Participants Electronic materials related to various prenatal topics including preparation for birth, birthing options, and responsive parenting will be distributed twice a week for the first 4-weeks of the program. Starting week 5 of the 12-week intervention, participants will attend two in-person, group sessions per week with each session lasting approximately 60 minutes and will be held at a local community center located close to the recruitment clinics. Control: This is a 12-week basic prenatal education class.
Physical Activity	48.0 units on a scale Standard Deviation 17.8	35.9 units on a scale Standard Deviation 9.11

Adverse Events

Intervention

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Intervention n=26 participants at risk；n=25 participants at risk During the first four weeks of the MBMM+ program, participants will receive electronic informational handouts covering topics on weight management as well as the benefits and safety concerns related to prenatal physical activity. Starting week 5 of the 12-week intervention, participants will attend two in-person, group physical activity sessions per week with each session lasting approximately 60 minutes and will be held at a local community center located close to the recruitment clinics. Sessions will be held on weekday evenings and weekend mornings as these times were preferred by pregnant women. Each session will include both didactic and experiential components to increase knowledge and skill building. Please note that all in-person sessions were moved to an online platform due to Covid. My Baby My Move +: This is a community-based, peer-led 12-week wellness intervention to decrease excessive gestational weight gain.	Control n=24 participants at risk Electronic materials related to various prenatal topics including preparation for birth, birthing options, and responsive parenting will be distributed twice a week for the first 4-weeks of the program. Starting week 5 of the 12-week intervention, participants will attend two in-person, group sessions per week with each session lasting approximately 60 minutes and will be held at a local community center located close to the recruitment clinics. Please note that all in-person sessions were moved to an online platform due to Covid. Control: This is a 12-week basic prenatal education class.
Pregnancy, puerperium and perinatal conditions miscarriage	4.0% 1/25 • Number of events 1 • 16 months serious adverse event - miscarriage.	0.00% 0/24 • 16 months serious adverse event - miscarriage.

Other adverse events

Adverse event data not reported

Additional Information

Jenn Leiferman

Colorado School of Public Health

Phone: 303-724-4386

Email: jenn.leiferman@cuanschutz.edu

Results disclosure agreements

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