Trial Outcomes & Findings for Using Mental Imagination to Prevent Excessive Gestational Weight Gain in Overweight and Obese Pregnant Women (NCT NCT04623008)
NCT ID: NCT04623008
Last Updated: 2025-01-03
Results Overview
Data extracted from electronic medical record
COMPLETED
NA
70 participants
Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
2025-01-03
Participant Flow
Between February, 2021 and March, 2022, Clinicians at collaborating sites referred pregnant patients to our study. The study research assistants screened the potential participants for eligibility over the phone.
Eligible participants completed baseline measures; had body mass index (BMI) of 25.0-45.0 kg/m2 (calculated using self reported height and pre-pregnancy weight) and be between 18 and 45 years old. We excluded potential participants with self-reported history of ≥ 3 miscarriages, eating disorder, and diagnosed hypertension and type 1 or 2 diabetes, or contraindications to walking.
Participant milestones
| Measure |
Goal-Oriented Episodic Future Thinking (GOEFT) Intervention
In addition to usual prenatal care, intervention participants will receive a 20-week intervention via web and individual health counseling. The intervention topics focus on stress management, healthy eating, and physical activity.
Goal-Oriented Episodic Future Thinking: Individuals in the intervention group will receive a 20-week web-based intervention and individual health coaching focused on stress management, healthy eating and physical activity.
|
Usual Prenatal Care
The usual prenatal care group will receive usual care from their providers
|
|---|---|---|
|
Baseline to T2
STARTED
|
35
|
35
|
|
Baseline to T2
COMPLETED
|
31
|
33
|
|
Baseline to T2
NOT COMPLETED
|
4
|
2
|
|
Baseline to T3
STARTED
|
35
|
35
|
|
Baseline to T3
COMPLETED
|
31
|
33
|
|
Baseline to T3
NOT COMPLETED
|
4
|
2
|
|
T2 toT3
STARTED
|
31
|
33
|
|
T2 toT3
COMPLETED
|
31
|
33
|
|
T2 toT3
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Goal-Oriented Episodic Future Thinking (GOEFT) Intervention
In addition to usual prenatal care, intervention participants will receive a 20-week intervention via web and individual health counseling. The intervention topics focus on stress management, healthy eating, and physical activity.
Goal-Oriented Episodic Future Thinking: Individuals in the intervention group will receive a 20-week web-based intervention and individual health coaching focused on stress management, healthy eating and physical activity.
|
Usual Prenatal Care
The usual prenatal care group will receive usual care from their providers
|
|---|---|---|
|
Baseline to T2
Withdrawal by Subject
|
4
|
2
|
|
Baseline to T3
Withdrawal by Subject
|
4
|
2
|
Baseline Characteristics
Using Mental Imagination to Prevent Excessive Gestational Weight Gain in Overweight and Obese Pregnant Women
Baseline characteristics by cohort
| Measure |
Goal-Oriented Episodic Future Thinking (GOEFT) Intervention
n=35 Participants
In addition to usual prenatal care, intervention participants will receive a 20-week intervention via web and individual health counseling. The intervention topics focus on stress management, healthy eating, and physical activity.
Goal-Oriented Episodic Future Thinking: Individuals in the intervention group will receive a 20-week web-based intervention and individual health coaching focused on stress management, healthy eating and physical activity.
|
Usual Prenatal Care
n=35 Participants
The usual prenatal care group will receive usual care from their providers
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.3 years
STANDARD_DEVIATION 4.3 • n=5 Participants
|
32.0 years
STANDARD_DEVIATION 3.8 • n=7 Participants
|
32.2 years
STANDARD_DEVIATION 4.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
70 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 White
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
8 participants
n=5 Participants
|
2 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
25 participants
n=5 Participants
|
26 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
35 participants
n=7 Participants
|
70 participants
n=5 Participants
|
|
Marital Status
Single, never married
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Marital Status
Married
|
31 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Marital Status
In a domestic partnership
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)Data extracted from electronic medical record
Outcome measures
| Measure |
Goal-Oriented Episodic Future Thinking (GOEFT) Intervention
n=31 Participants
In addition to usual prenatal care, intervention participants will receive a 20-week intervention via web and individual health counseling. The intervention topics focus on stress management, healthy eating, and physical activity.
Goal-Oriented Episodic Future Thinking: Individuals in the intervention group will receive a 20-week web-based intervention and individual health coaching focused on stress management, healthy eating and physical activity.
|
Usual Prenatal Care
n=33 Participants
The usual prenatal care group will receive usual care from their providers
|
|---|---|---|
|
Percent Change in Body Weight
|
10.9 percentage change
Standard Deviation 8.8
|
9.6 percentage change
Standard Deviation 11.0
|
PRIMARY outcome
Timeframe: 24-27 week-gestation (T2) to 35-37 week-gestation (T3)Data extracted from electronic medical record
Outcome measures
| Measure |
Goal-Oriented Episodic Future Thinking (GOEFT) Intervention
n=31 Participants
In addition to usual prenatal care, intervention participants will receive a 20-week intervention via web and individual health counseling. The intervention topics focus on stress management, healthy eating, and physical activity.
Goal-Oriented Episodic Future Thinking: Individuals in the intervention group will receive a 20-week web-based intervention and individual health coaching focused on stress management, healthy eating and physical activity.
|
Usual Prenatal Care
n=33 Participants
The usual prenatal care group will receive usual care from their providers
|
|---|---|---|
|
Percent Change in Body Weight
|
14.0 percent change
Standard Deviation 7.1
|
13.9 percent change
Standard Deviation 12.6
|
PRIMARY outcome
Timeframe: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)Data extracted from electronic medical record
Outcome measures
| Measure |
Goal-Oriented Episodic Future Thinking (GOEFT) Intervention
n=31 Participants
In addition to usual prenatal care, intervention participants will receive a 20-week intervention via web and individual health counseling. The intervention topics focus on stress management, healthy eating, and physical activity.
Goal-Oriented Episodic Future Thinking: Individuals in the intervention group will receive a 20-week web-based intervention and individual health coaching focused on stress management, healthy eating and physical activity.
|
Usual Prenatal Care
n=33 Participants
The usual prenatal care group will receive usual care from their providers
|
|---|---|---|
|
Percent Change in Body Weight
|
24.9 percent change
Standard Deviation 12.2
|
23.5 percent change
Standard Deviation 10.8
|
SECONDARY outcome
Timeframe: 24-27 week-gestation (T2) to 35-37 week-gestation (T3)Data extracted from electronic medical record. Percentage of participants who were diagnosed with Gestational Diabetes during the study timeframe.
Outcome measures
| Measure |
Goal-Oriented Episodic Future Thinking (GOEFT) Intervention
n=31 Participants
In addition to usual prenatal care, intervention participants will receive a 20-week intervention via web and individual health counseling. The intervention topics focus on stress management, healthy eating, and physical activity.
Goal-Oriented Episodic Future Thinking: Individuals in the intervention group will receive a 20-week web-based intervention and individual health coaching focused on stress management, healthy eating and physical activity.
|
Usual Prenatal Care
n=33 Participants
The usual prenatal care group will receive usual care from their providers
|
|---|---|---|
|
Percentage of Participants Diagnosed With Gestational Diabetes
|
4 percentage of participants
Standard Deviation 12.9
|
5 percentage of participants
Standard Deviation 15.2
|
SECONDARY outcome
Timeframe: 24-27 week-gestation (T2) to 35-37 week-gestation (T3)Data extracted from electronic medical record. Percentage of participants diagnosed with Gestational Hypertension in the study timeframe.
Outcome measures
| Measure |
Goal-Oriented Episodic Future Thinking (GOEFT) Intervention
n=31 Participants
In addition to usual prenatal care, intervention participants will receive a 20-week intervention via web and individual health counseling. The intervention topics focus on stress management, healthy eating, and physical activity.
Goal-Oriented Episodic Future Thinking: Individuals in the intervention group will receive a 20-week web-based intervention and individual health coaching focused on stress management, healthy eating and physical activity.
|
Usual Prenatal Care
n=33 Participants
The usual prenatal care group will receive usual care from their providers
|
|---|---|---|
|
Percentage of Participants Diagnosed With Gestational Hypertension
|
4 percent of participants
Standard Deviation 12.9
|
2 percent of participants
Standard Deviation 6.1
|
SECONDARY outcome
Timeframe: 35-37 week-gestation (T3)Data extracted from electronic medical record. Percentage of participants who experienced Cesarean Delivery.
Outcome measures
| Measure |
Goal-Oriented Episodic Future Thinking (GOEFT) Intervention
n=31 Participants
In addition to usual prenatal care, intervention participants will receive a 20-week intervention via web and individual health counseling. The intervention topics focus on stress management, healthy eating, and physical activity.
Goal-Oriented Episodic Future Thinking: Individuals in the intervention group will receive a 20-week web-based intervention and individual health coaching focused on stress management, healthy eating and physical activity.
|
Usual Prenatal Care
n=33 Participants
The usual prenatal care group will receive usual care from their providers
|
|---|---|---|
|
Percentage of Participants With Cesarean Delivery
|
9 percentage of participants
Standard Deviation 29.0
|
9 percentage of participants
Standard Deviation 27.3
|
SECONDARY outcome
Timeframe: 35-37 week-gestation (T3)Data extracted from electronic medical record. Newborn Body Weight taken at birth.
Outcome measures
| Measure |
Goal-Oriented Episodic Future Thinking (GOEFT) Intervention
n=31 Participants
In addition to usual prenatal care, intervention participants will receive a 20-week intervention via web and individual health counseling. The intervention topics focus on stress management, healthy eating, and physical activity.
Goal-Oriented Episodic Future Thinking: Individuals in the intervention group will receive a 20-week web-based intervention and individual health coaching focused on stress management, healthy eating and physical activity.
|
Usual Prenatal Care
n=33 Participants
The usual prenatal care group will receive usual care from their providers
|
|---|---|---|
|
Newborn Body Weight
|
3493 grams
Standard Deviation 327.7
|
3503 grams
Standard Deviation 483.2
|
SECONDARY outcome
Timeframe: 35-37 week-gestation (T3)Gestational age for each participant was extracted from electronic medical record and births before 37 weeks gestation were considered to be premature. The number of premature births was averaged within the study groups.
Outcome measures
| Measure |
Goal-Oriented Episodic Future Thinking (GOEFT) Intervention
n=31 Participants
In addition to usual prenatal care, intervention participants will receive a 20-week intervention via web and individual health counseling. The intervention topics focus on stress management, healthy eating, and physical activity.
Goal-Oriented Episodic Future Thinking: Individuals in the intervention group will receive a 20-week web-based intervention and individual health coaching focused on stress management, healthy eating and physical activity.
|
Usual Prenatal Care
n=33 Participants
The usual prenatal care group will receive usual care from their providers
|
|---|---|---|
|
Percentage of Participants With Premature (<37 Weeks Gestation) Births
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)Assessed using the National Cancer Institute Automated Self-Administered 24-hour Recall (ASA24). Participants completed 24-hour Dietary Recalls on two random days over a week. The variable of interest - calories (Kcal) - values for the 2 24-hour periods were added to ascertain the total amount consumed at the specific data collection time periods. Data from Baseline (T1) was compared to that collected at T2 for each participant and averaged for an aggregate score. Positive numbers represent an increase in calories consumed, negative numbers represent a decrease in calories consumed. Only participants who completed 2 days worth of dietary data were included in this analysis.
Outcome measures
| Measure |
Goal-Oriented Episodic Future Thinking (GOEFT) Intervention
n=12 Participants
In addition to usual prenatal care, intervention participants will receive a 20-week intervention via web and individual health counseling. The intervention topics focus on stress management, healthy eating, and physical activity.
Goal-Oriented Episodic Future Thinking: Individuals in the intervention group will receive a 20-week web-based intervention and individual health coaching focused on stress management, healthy eating and physical activity.
|
Usual Prenatal Care
n=24 Participants
The usual prenatal care group will receive usual care from their providers
|
|---|---|---|
|
Percentage of Change in Dietary Intake Behaviors - Caloric Intake (Kcal)
|
162.9 percentage of change
Standard Deviation 545.7
|
-149 percentage of change
Standard Deviation 655.9
|
SECONDARY outcome
Timeframe: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)Assessed using the National Cancer Institute Automated Self-Administered 24-hour Recall (ASA24). Participants completed 24-hour Dietary Recalls on two random days over a week. The variable of interest - fat (gm) - values for the 2 24-hour periods were added to ascertain the total amount consumed at the specific data collection time periods. Data from Baseline (T1) was compared to that collected at T2 for each participant and averaged for an aggregate score. Positive numbers represent an increase in fat consumed, negative numbers represent a decrease in fat consumed. Only participants who completed 2 days worth of dietary data were included in this analysis.
Outcome measures
| Measure |
Goal-Oriented Episodic Future Thinking (GOEFT) Intervention
n=12 Participants
In addition to usual prenatal care, intervention participants will receive a 20-week intervention via web and individual health counseling. The intervention topics focus on stress management, healthy eating, and physical activity.
Goal-Oriented Episodic Future Thinking: Individuals in the intervention group will receive a 20-week web-based intervention and individual health coaching focused on stress management, healthy eating and physical activity.
|
Usual Prenatal Care
n=24 Participants
The usual prenatal care group will receive usual care from their providers
|
|---|---|---|
|
Percentage of Change in Dietary Intake Behaviors - Fat (gm)
|
9.89 percentage of change
Standard Deviation 32.74
|
-0.84 percentage of change
Standard Deviation 40.73
|
SECONDARY outcome
Timeframe: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)Assessed using the National Cancer Institute Automated Self-Administered 24-hour Recall (ASA24). Participants completed 24-hour Dietary Recalls on two random days over a week. The variable of interest - fruit (cup) - values for the 2 24-hour periods were added to ascertain the total amount consumed at the specific data collection time periods. Data from Baseline (T1) was compared to that collected at T2 for each participant and averaged for an aggregate score. Positive numbers represent an increase in fruit consumed, negative numbers represent a decrease in fruit consumed. Only participants who completed 2 days worth of dietary data were included in this analysis.
Outcome measures
| Measure |
Goal-Oriented Episodic Future Thinking (GOEFT) Intervention
n=12 Participants
In addition to usual prenatal care, intervention participants will receive a 20-week intervention via web and individual health counseling. The intervention topics focus on stress management, healthy eating, and physical activity.
Goal-Oriented Episodic Future Thinking: Individuals in the intervention group will receive a 20-week web-based intervention and individual health coaching focused on stress management, healthy eating and physical activity.
|
Usual Prenatal Care
n=24 Participants
The usual prenatal care group will receive usual care from their providers
|
|---|---|---|
|
Percentage of Change in Dietary Intake Behaviors - Fruit (Cup)
|
0.63 percentage of change
Standard Deviation 2.50
|
-0.25 percentage of change
Standard Deviation 1.37
|
SECONDARY outcome
Timeframe: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)Assessed using the National Cancer Institute Automated Self-Administered 24-hour Recall (ASA24). Participants completed 24-hour Dietary Recalls on two random days over a week. The variable of interest - vegetables (cup) - values for the 2 24-hour periods were added to ascertain the total amount consumed at the specific data collection time periods. Data from Baseline (T1) was compared to that collected at T2 for each participant and averaged for an aggregate score. Positive numbers represent an increase in vegetables consumed, negative numbers represent a decrease in vegetables consumed. Only participants who completed 2 days worth of dietary data were included in this analysis.
Outcome measures
| Measure |
Goal-Oriented Episodic Future Thinking (GOEFT) Intervention
n=12 Participants
In addition to usual prenatal care, intervention participants will receive a 20-week intervention via web and individual health counseling. The intervention topics focus on stress management, healthy eating, and physical activity.
Goal-Oriented Episodic Future Thinking: Individuals in the intervention group will receive a 20-week web-based intervention and individual health coaching focused on stress management, healthy eating and physical activity.
|
Usual Prenatal Care
n=24 Participants
The usual prenatal care group will receive usual care from their providers
|
|---|---|---|
|
Percentage of Change in Dietary Intake Behaviors - Vegetable (Cup)
|
0.18 percentage of change
Standard Deviation 1.65
|
0.22 percentage of change
Standard Deviation 0.84
|
SECONDARY outcome
Timeframe: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)Assessed using the National Cancer Institute Automated Self-Administered 24-hour Recall (ASA24). Participants completed 24-hour Dietary Recalls on two random days over a week. The variable of interest - added sugars teaspoon or 4 gm) - values for the 2 24-hour periods were added to ascertain the total amount consumed at the specific data collection time periods. Data from Baseline (T1) was compared to that collected at T2 for each participant and averaged for an aggregate score. Positive numbers represent an increase in added sugars consumed, negative numbers represent a decrease in added sugars consumed. Only participants who completed 2 days worth of dietary data were included in this analysis.
Outcome measures
| Measure |
Goal-Oriented Episodic Future Thinking (GOEFT) Intervention
n=12 Participants
In addition to usual prenatal care, intervention participants will receive a 20-week intervention via web and individual health counseling. The intervention topics focus on stress management, healthy eating, and physical activity.
Goal-Oriented Episodic Future Thinking: Individuals in the intervention group will receive a 20-week web-based intervention and individual health coaching focused on stress management, healthy eating and physical activity.
|
Usual Prenatal Care
n=24 Participants
The usual prenatal care group will receive usual care from their providers
|
|---|---|---|
|
Percentage of Change in Dietary Intake Behaviors - Added Sugars (Teaspoon or 4gm)
|
2.35 percentage of change
Standard Deviation 7.26
|
-2.99 percentage of change
Standard Deviation 8.16
|
SECONDARY outcome
Timeframe: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)Assessed using the National Cancer Institute Automated Self-Administered 24-hour Recall (ASA24). Participants completed 24-hour Dietary Recalls on two random days over a week. The variable of interest - calories (Kcal) - values for the 2 24-hour periods were added to ascertain the total amount consumed at the specific data collection time periods. Data from Baseline (T1) was compared to that collected at T3 for each participant and averaged for an aggregate score. Positive numbers represent an increase in calories consumed, negative numbers represent a decrease in calories consumed. Only participants who completed 2 days worth of dietary data were included in this analysis.
Outcome measures
| Measure |
Goal-Oriented Episodic Future Thinking (GOEFT) Intervention
n=15 Participants
In addition to usual prenatal care, intervention participants will receive a 20-week intervention via web and individual health counseling. The intervention topics focus on stress management, healthy eating, and physical activity.
Goal-Oriented Episodic Future Thinking: Individuals in the intervention group will receive a 20-week web-based intervention and individual health coaching focused on stress management, healthy eating and physical activity.
|
Usual Prenatal Care
n=18 Participants
The usual prenatal care group will receive usual care from their providers
|
|---|---|---|
|
Percentage of Change in Dietary Intake Behaviors - Caloric Intake (Kcal)
|
98.34 percentage of change
Standard Deviation 651.4
|
-217 percentage of change
Standard Deviation 627.0
|
SECONDARY outcome
Timeframe: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)Assessed using the National Cancer Institute Automated Self-Administered 24-hour Recall (ASA24). Participants completed 24-hour Dietary Recalls on two random days over a week. The variable of interest - fat (gm) - values for the 2 24-hour periods were added to ascertain the total amount consumed at the specific data collection time periods. Data from Baseline (T1) was compared to that collected at T3 for each participant and averaged for an aggregate score. Positive numbers represent an increase in fat consumed, negative numbers represent a decrease in fat consumed. Only participants who completed 2 days worth of dietary data were included in this analysis.
Outcome measures
| Measure |
Goal-Oriented Episodic Future Thinking (GOEFT) Intervention
n=15 Participants
In addition to usual prenatal care, intervention participants will receive a 20-week intervention via web and individual health counseling. The intervention topics focus on stress management, healthy eating, and physical activity.
Goal-Oriented Episodic Future Thinking: Individuals in the intervention group will receive a 20-week web-based intervention and individual health coaching focused on stress management, healthy eating and physical activity.
|
Usual Prenatal Care
n=18 Participants
The usual prenatal care group will receive usual care from their providers
|
|---|---|---|
|
Percentage of Change in Dietary Intake Behaviors - Fat Intake (gm)
|
15.18 percentage of change
Standard Deviation 43.30
|
-11.1 percentage of change
Standard Deviation 38.83
|
SECONDARY outcome
Timeframe: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)Assessed using the National Cancer Institute Automated Self-Administered 24-hour Recall (ASA24). Participants completed 24-hour Dietary Recalls on two random days over a week. The variable of interest - fruit (cup) - values for the 2 24-hour periods were added to ascertain the total amount consumed at the specific data collection time periods. Data from Baseline (T1) was compared to that collected at T3 for each participant and averaged for an aggregate score. Positive numbers represent an increase in fruit consumed, negative numbers represent a decrease in fruit consumed. Only participants who completed 2 days worth of dietary data were included in this analysis.
Outcome measures
| Measure |
Goal-Oriented Episodic Future Thinking (GOEFT) Intervention
n=15 Participants
In addition to usual prenatal care, intervention participants will receive a 20-week intervention via web and individual health counseling. The intervention topics focus on stress management, healthy eating, and physical activity.
Goal-Oriented Episodic Future Thinking: Individuals in the intervention group will receive a 20-week web-based intervention and individual health coaching focused on stress management, healthy eating and physical activity.
|
Usual Prenatal Care
n=18 Participants
The usual prenatal care group will receive usual care from their providers
|
|---|---|---|
|
Percentage of Change in Dietary Intake Behaviors - Fruit Intake (Cups)
|
0.12 percentage of change
Standard Deviation 1.07
|
0.19 percentage of change
Standard Deviation 1.32
|
SECONDARY outcome
Timeframe: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)Assessed using the National Cancer Institute Automated Self-Administered 24-hour Recall (ASA24). Participants completed 24-hour Dietary Recalls on two random days over a week. The variable of interest - vegetable (cup) - values for the 2 24-hour periods were added to ascertain the total amount consumed at the specific data collection time periods. Data from Baseline (T1) was compared to that collected at T3 for each participant and averaged for an aggregate score. Positive numbers represent an increase in vegetables consumed, negative numbers represent a decrease in vegetables consumed. Only participants who completed 2 days worth of dietary data were included in this analysis.
Outcome measures
| Measure |
Goal-Oriented Episodic Future Thinking (GOEFT) Intervention
n=15 Participants
In addition to usual prenatal care, intervention participants will receive a 20-week intervention via web and individual health counseling. The intervention topics focus on stress management, healthy eating, and physical activity.
Goal-Oriented Episodic Future Thinking: Individuals in the intervention group will receive a 20-week web-based intervention and individual health coaching focused on stress management, healthy eating and physical activity.
|
Usual Prenatal Care
n=18 Participants
The usual prenatal care group will receive usual care from their providers
|
|---|---|---|
|
Percentage of Change in Dietary Intake Behaviors - Vegetable Intake (Cups)
|
-0.11 percentage of change
Standard Deviation 1.65
|
0.08 percentage of change
Standard Deviation 1.34
|
SECONDARY outcome
Timeframe: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)Assessed using the National Cancer Institute Automated Self-Administered 24-hour Recall (ASA24). Participants completed 24-hour Dietary Recalls on two random days over a week. The variable of interest - added sugars (teaspoon or 4 gm) - values for the 2 24-hour periods were added to ascertain the total amount consumed at the specific data collection time periods. Data from Baseline (T1) was compared to that collected at T3 for each participant and averaged for an aggregate score. Positive numbers represent an increase in added sugars consumed, negative numbers represent a decrease in added sugars consumed. Only participants who completed 2 days worth of dietary data were included in this analysis.
Outcome measures
| Measure |
Goal-Oriented Episodic Future Thinking (GOEFT) Intervention
n=15 Participants
In addition to usual prenatal care, intervention participants will receive a 20-week intervention via web and individual health counseling. The intervention topics focus on stress management, healthy eating, and physical activity.
Goal-Oriented Episodic Future Thinking: Individuals in the intervention group will receive a 20-week web-based intervention and individual health coaching focused on stress management, healthy eating and physical activity.
|
Usual Prenatal Care
n=18 Participants
The usual prenatal care group will receive usual care from their providers
|
|---|---|---|
|
Percentage of Change in Dietary Intake Behaviors - Added Sugars Intake (gm)
|
3.08 percentage of change
Standard Deviation 13.27
|
-2.28 percentage of change
Standard Deviation 10.96
|
SECONDARY outcome
Timeframe: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)Assessed using Actigraph (GT3x), an objective measurement of physical activity. Investigators distributed the Actigraph in person participants' home (T2 and T3) to wear at the wrist at least seven consecutive days (≥ 10 hours/per day). The variable of interest - 7-day MET - values for the period was added to ascertain the total amount at the specific data collection time periods. Data from Baseline (T1) was compared to that collected at T2 for each participant and averaged for an aggregate score. Positive numbers represent an increase in physical activity negative numbers represent a decrease in physical. Only participants who completed the minimum requirement for reporting \[wear at the wrist at least seven consecutive days (≥ 10 hours/per day)\] were included in the analysis.
Outcome measures
| Measure |
Goal-Oriented Episodic Future Thinking (GOEFT) Intervention
n=23 Participants
In addition to usual prenatal care, intervention participants will receive a 20-week intervention via web and individual health counseling. The intervention topics focus on stress management, healthy eating, and physical activity.
Goal-Oriented Episodic Future Thinking: Individuals in the intervention group will receive a 20-week web-based intervention and individual health coaching focused on stress management, healthy eating and physical activity.
|
Usual Prenatal Care
n=30 Participants
The usual prenatal care group will receive usual care from their providers
|
|---|---|---|
|
Percentage of Change in Physical Activity - 7-Day Metabolic Equivalent of Task (MET)
|
1.77 percentage of change
Standard Deviation 9.31
|
3.65 percentage of change
Standard Deviation 9.85
|
SECONDARY outcome
Timeframe: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)Assessed using Actigraph (GT3x), an objective measurement of physical activity. Investigators distributed the Actigraph in person participants' home (T2 and T3) to wear at the wrist at least seven consecutive days (≥ 10 hours/per day). The variable of interest - 7-day MET - values for the period was added to ascertain the total amount at the specific data collection time periods. Data from Baseline (T1) was compared to that collected at T3 for each participant and averaged for an aggregate score. Positive numbers represent an increase in physical activity negative numbers represent a decrease in physical. Only participants who completed the minimum requirement for reporting \[wear at the wr
Outcome measures
| Measure |
Goal-Oriented Episodic Future Thinking (GOEFT) Intervention
n=18 Participants
In addition to usual prenatal care, intervention participants will receive a 20-week intervention via web and individual health counseling. The intervention topics focus on stress management, healthy eating, and physical activity.
Goal-Oriented Episodic Future Thinking: Individuals in the intervention group will receive a 20-week web-based intervention and individual health coaching focused on stress management, healthy eating and physical activity.
|
Usual Prenatal Care
n=28 Participants
The usual prenatal care group will receive usual care from their providers
|
|---|---|---|
|
Percentage of Change in Physical Activity - 7-Day Metabolic Equivalent of Task (MET)
|
3.06 percentage of change
Standard Deviation 7.09
|
1.13 percentage of change
Standard Deviation 11.40
|
SECONDARY outcome
Timeframe: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)Will be measured using Treatment Self-Regulation Questionnaire (6 items) to measure autonomous motivation for Physical Activity (6 items) Values are: 1 - Not At All True, 2, 3, 4 - Somewhat True, 5, 6, 7 - Very True The investigators will sum 6 items to create a composite score, ranging from 6 to 42. Higher scores indicate higher autonomous motivation for Physical Activity.
Outcome measures
| Measure |
Goal-Oriented Episodic Future Thinking (GOEFT) Intervention
n=11 Participants
In addition to usual prenatal care, intervention participants will receive a 20-week intervention via web and individual health counseling. The intervention topics focus on stress management, healthy eating, and physical activity.
Goal-Oriented Episodic Future Thinking: Individuals in the intervention group will receive a 20-week web-based intervention and individual health coaching focused on stress management, healthy eating and physical activity.
|
Usual Prenatal Care
n=26 Participants
The usual prenatal care group will receive usual care from their providers
|
|---|---|---|
|
Change in Autonomous Motivation for Physical Activity
|
1.64 score on a scale
Standard Deviation 2.80
|
0.92 score on a scale
Standard Deviation 5.55
|
SECONDARY outcome
Timeframe: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)Will be measured using Treatment Self-Regulation Questionnaire (6 items) to measure autonomous motivation for Physical Activity (6 items) Values are: 1 - Not At All True, 2, 3, 4 - Somewhat True, 5, 6, 7 - Very True The investigators will sum 6 items to create a composite score, ranging from 6 to 42. Higher scores indicate higher autonomous motivation for Physical Activity.
Outcome measures
| Measure |
Goal-Oriented Episodic Future Thinking (GOEFT) Intervention
n=14 Participants
In addition to usual prenatal care, intervention participants will receive a 20-week intervention via web and individual health counseling. The intervention topics focus on stress management, healthy eating, and physical activity.
Goal-Oriented Episodic Future Thinking: Individuals in the intervention group will receive a 20-week web-based intervention and individual health coaching focused on stress management, healthy eating and physical activity.
|
Usual Prenatal Care
n=18 Participants
The usual prenatal care group will receive usual care from their providers
|
|---|---|---|
|
Change in Autonomous Motivation for Physical Activity
|
-1.60 score on a scale
Standard Deviation 4.79
|
-1.26 score on a scale
Standard Deviation 6.81
|
SECONDARY outcome
Timeframe: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)Will be measured using Treatment Self-Regulation Questionnaire (6 items) to measure autonomous motivation for stress management (6 items) Values are: 1 - Not At All True, 2, 3, 4 - Somewhat True, 5, 6, 7 - Very True The investigators will sum 6 items to create a composite score, ranging from 6 to 42. Higher scores indicate higher autonomous motivation for stress management.
Outcome measures
| Measure |
Goal-Oriented Episodic Future Thinking (GOEFT) Intervention
n=11 Participants
In addition to usual prenatal care, intervention participants will receive a 20-week intervention via web and individual health counseling. The intervention topics focus on stress management, healthy eating, and physical activity.
Goal-Oriented Episodic Future Thinking: Individuals in the intervention group will receive a 20-week web-based intervention and individual health coaching focused on stress management, healthy eating and physical activity.
|
Usual Prenatal Care
n=26 Participants
The usual prenatal care group will receive usual care from their providers
|
|---|---|---|
|
Change in Autonomous Motivation for Stress Management
|
-0.09 score on a scale
Standard Deviation 2.84
|
1.54 score on a scale
Standard Deviation 4.96
|
SECONDARY outcome
Timeframe: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)Will be measured using Treatment Self-Regulation Questionnaire (6 items) to measure autonomous motivation for stress management (6 items) Values are: 1 - Not At AllTrue, 2, 3, 4 - Somewhat True, 5, 6, 7 - Very True The investigators will sum 6 items to create a composite score, ranging from 6 to 42. Higher scores indicate higher autonomous motivation for stress managment.
Outcome measures
| Measure |
Goal-Oriented Episodic Future Thinking (GOEFT) Intervention
n=14 Participants
In addition to usual prenatal care, intervention participants will receive a 20-week intervention via web and individual health counseling. The intervention topics focus on stress management, healthy eating, and physical activity.
Goal-Oriented Episodic Future Thinking: Individuals in the intervention group will receive a 20-week web-based intervention and individual health coaching focused on stress management, healthy eating and physical activity.
|
Usual Prenatal Care
n=18 Participants
The usual prenatal care group will receive usual care from their providers
|
|---|---|---|
|
Change in Autonomous Motivation for Stress Management
|
-0.27 score on a scale
Standard Deviation 5.38
|
-0.68 score on a scale
Standard Deviation 6.71
|
SECONDARY outcome
Timeframe: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)Will be measured using Treatment Self-Regulation Questionnaire (6 items) to measure autonomous motivation for Healthy Eating (6 items) Values are: 1 - Not At All True, 2, 3, 4 - Somewhat True, 5, 6, 7 - Very True The investigators will sum 6 items to create a composite score, ranging from 6 to 42. Higher scores indicate higher autonomous motivation for Healthy Eating.
Outcome measures
| Measure |
Goal-Oriented Episodic Future Thinking (GOEFT) Intervention
n=11 Participants
In addition to usual prenatal care, intervention participants will receive a 20-week intervention via web and individual health counseling. The intervention topics focus on stress management, healthy eating, and physical activity.
Goal-Oriented Episodic Future Thinking: Individuals in the intervention group will receive a 20-week web-based intervention and individual health coaching focused on stress management, healthy eating and physical activity.
|
Usual Prenatal Care
n=26 Participants
The usual prenatal care group will receive usual care from their providers
|
|---|---|---|
|
Change in Autonomous Motivation for Healthy Eating
|
2.00 score on a scale
Standard Deviation 3.29
|
0.38 score on a scale
Standard Deviation 4.53
|
SECONDARY outcome
Timeframe: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)Will be measured using Treatment Self-Regulation Questionnaire (6 items) to measure autonomous motivation for Healthy Eating (6 items) Values are: 1 - Not At All True, 2, 3, 4 - Somewhat True, 5, 6, 7 - Very True The investigators will sum 6 items to create a composite score, ranging from 6 to 42. Higher scores indicate higher autonomous motivation for Healthy Eating
Outcome measures
| Measure |
Goal-Oriented Episodic Future Thinking (GOEFT) Intervention
n=14 Participants
In addition to usual prenatal care, intervention participants will receive a 20-week intervention via web and individual health counseling. The intervention topics focus on stress management, healthy eating, and physical activity.
Goal-Oriented Episodic Future Thinking: Individuals in the intervention group will receive a 20-week web-based intervention and individual health coaching focused on stress management, healthy eating and physical activity.
|
Usual Prenatal Care
n=18 Participants
The usual prenatal care group will receive usual care from their providers
|
|---|---|---|
|
Change in Autonomous Motivation for Healthy Eating
|
-0.93 score on a scale
Standard Deviation 5.75
|
-2.95 score on a scale
Standard Deviation 6.70
|
SECONDARY outcome
Timeframe: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)Will be measured using a "Survey for Healthy Eating Self-efficacy" (8 items) Values are: 1 - Not At All Confident, 2 - Not Too Confident, 3 - Somewhat Confident, 4 - Very Confident. The investigators will sum all 8 items to create a composite score, ranging from 8 to 32. The higher score, the higher healthy eating self-efficacy.
Outcome measures
| Measure |
Goal-Oriented Episodic Future Thinking (GOEFT) Intervention
n=11 Participants
In addition to usual prenatal care, intervention participants will receive a 20-week intervention via web and individual health counseling. The intervention topics focus on stress management, healthy eating, and physical activity.
Goal-Oriented Episodic Future Thinking: Individuals in the intervention group will receive a 20-week web-based intervention and individual health coaching focused on stress management, healthy eating and physical activity.
|
Usual Prenatal Care
n=26 Participants
The usual prenatal care group will receive usual care from their providers
|
|---|---|---|
|
Change in Healthy Eating Self-efficacy
|
2.27 score on a scale
Standard Deviation 3.58
|
1.31 score on a scale
Standard Deviation 3.58
|
SECONDARY outcome
Timeframe: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)Will be measured using a "Survey for Healthy Eating Self-efficacy" (8 items) Values are: 1 - Not At All Confident, 2 - Not Too Confident, 3 - Somewhat Confident, 4 - Very Confident The investigators will sum all 8 items to create a composite score, ranging from 8 to 32. The higher score, the higher healthy eating self-efficacy.
Outcome measures
| Measure |
Goal-Oriented Episodic Future Thinking (GOEFT) Intervention
n=14 Participants
In addition to usual prenatal care, intervention participants will receive a 20-week intervention via web and individual health counseling. The intervention topics focus on stress management, healthy eating, and physical activity.
Goal-Oriented Episodic Future Thinking: Individuals in the intervention group will receive a 20-week web-based intervention and individual health coaching focused on stress management, healthy eating and physical activity.
|
Usual Prenatal Care
n=18 Participants
The usual prenatal care group will receive usual care from their providers
|
|---|---|---|
|
Change in Healthy Eating Self-efficacy
|
2.80 score on a scale
Standard Deviation 3.32
|
0.84 score on a scale
Standard Deviation 4.45
|
SECONDARY outcome
Timeframe: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)Will be measured using a "Survey for Coping Self-efficacy" (10 items) Values are: 1 - Not At All Confident, 2 - Not Too Confident, 3 - Somewhat Confident, 4 - Very Confident The investigators will sum 10 items to create a composite score, ranging from 10 to 40. Higher scores indicate higher coping self-efficacy.
Outcome measures
| Measure |
Goal-Oriented Episodic Future Thinking (GOEFT) Intervention
n=11 Participants
In addition to usual prenatal care, intervention participants will receive a 20-week intervention via web and individual health counseling. The intervention topics focus on stress management, healthy eating, and physical activity.
Goal-Oriented Episodic Future Thinking: Individuals in the intervention group will receive a 20-week web-based intervention and individual health coaching focused on stress management, healthy eating and physical activity.
|
Usual Prenatal Care
n=26 Participants
The usual prenatal care group will receive usual care from their providers
|
|---|---|---|
|
Change in Coping Self-efficacy
|
1.09 score on a scale
Standard Deviation 4.72
|
1.35 score on a scale
Standard Deviation 4.34
|
SECONDARY outcome
Timeframe: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)Will be measured using a "Survey for Coping Self-efficacy" (10 items) Values are: 1 - Not At All Confident, 2 - Not Too Confident, 3 - Somewhat Confident, 4 - Very Confident The investigators will sum 10 items to create a composite score, ranging from 10 to 40. Higher scores indicate higher coping self-efficacy.
Outcome measures
| Measure |
Goal-Oriented Episodic Future Thinking (GOEFT) Intervention
n=14 Participants
In addition to usual prenatal care, intervention participants will receive a 20-week intervention via web and individual health counseling. The intervention topics focus on stress management, healthy eating, and physical activity.
Goal-Oriented Episodic Future Thinking: Individuals in the intervention group will receive a 20-week web-based intervention and individual health coaching focused on stress management, healthy eating and physical activity.
|
Usual Prenatal Care
n=18 Participants
The usual prenatal care group will receive usual care from their providers
|
|---|---|---|
|
Change in Coping Self-efficacy
|
4.07 score on a scale
Standard Deviation 6.06
|
1.21 score on a scale
Standard Deviation 3.28
|
SECONDARY outcome
Timeframe: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)Will be measured using a "Survey for Physical Activity Self-efficacy" (10 items) that ask participants' confidence in performing the specific activity. Values are: 1 - Not At All Confident, 2 - Not Too Confident, 3 - Somewhat Confident, 4 - Very Confident The investigators will sum all 10 items to create a composite score, ranging from 10 to 40. The higher score, the higher physical activity self-efficacy.
Outcome measures
| Measure |
Goal-Oriented Episodic Future Thinking (GOEFT) Intervention
n=11 Participants
In addition to usual prenatal care, intervention participants will receive a 20-week intervention via web and individual health counseling. The intervention topics focus on stress management, healthy eating, and physical activity.
Goal-Oriented Episodic Future Thinking: Individuals in the intervention group will receive a 20-week web-based intervention and individual health coaching focused on stress management, healthy eating and physical activity.
|
Usual Prenatal Care
n=26 Participants
The usual prenatal care group will receive usual care from their providers
|
|---|---|---|
|
Change in Physical Activity Self-efficacy
|
2.45 score on a scale
Standard Deviation 5.89
|
1.19 score on a scale
Standard Deviation 4.42
|
SECONDARY outcome
Timeframe: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)Will be measured using a "Survey for Physical Activity Self-efficacy" (10 items) that ask participants' confidence in performing the specific activity. Values are: 1 - Not At All Confident, 2 - Not Too Confident, 3 - Somewhat Confident, 4 - Very Confident The investigators will sum all 10 items to create a composite score, ranging from 10 to 40. The higher score, the higher physical activity self-efficacy.
Outcome measures
| Measure |
Goal-Oriented Episodic Future Thinking (GOEFT) Intervention
n=14 Participants
In addition to usual prenatal care, intervention participants will receive a 20-week intervention via web and individual health counseling. The intervention topics focus on stress management, healthy eating, and physical activity.
Goal-Oriented Episodic Future Thinking: Individuals in the intervention group will receive a 20-week web-based intervention and individual health coaching focused on stress management, healthy eating and physical activity.
|
Usual Prenatal Care
n=18 Participants
The usual prenatal care group will receive usual care from their providers
|
|---|---|---|
|
Change in Physical Activity Self-efficacy
|
1.40 score on a scale
Standard Deviation 5.17
|
2.00 score on a scale
Standard Deviation 3.87
|
SECONDARY outcome
Timeframe: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)The Emotion Regulation Questionnaire (10 items) was used to measure emotional control. The questionnaire asked participants to report the use of emotional regulatory process using a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). After revise coding 4 items, we summed responses of 10 items to create an emotional control score (ranged from 10 to 70). Higher scores indicated better emotional control.
Outcome measures
| Measure |
Goal-Oriented Episodic Future Thinking (GOEFT) Intervention
n=11 Participants
In addition to usual prenatal care, intervention participants will receive a 20-week intervention via web and individual health counseling. The intervention topics focus on stress management, healthy eating, and physical activity.
Goal-Oriented Episodic Future Thinking: Individuals in the intervention group will receive a 20-week web-based intervention and individual health coaching focused on stress management, healthy eating and physical activity.
|
Usual Prenatal Care
n=26 Participants
The usual prenatal care group will receive usual care from their providers
|
|---|---|---|
|
Change in Emotion Regulation
|
3.64 score on a scale
Standard Deviation 6.52
|
-0.50 score on a scale
Standard Deviation 5.26
|
SECONDARY outcome
Timeframe: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)The Emotion Regulation Questionnaire (10 items) was used to measure emotional control. The questionnaire asked participants to report the use of emotional regulatory process using a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). After revise coding 4 items, we summed responses of 10 items to create an emotional control score (ranged from 10 to 70). Higher scores indicated better emotional control.
Outcome measures
| Measure |
Goal-Oriented Episodic Future Thinking (GOEFT) Intervention
n=14 Participants
In addition to usual prenatal care, intervention participants will receive a 20-week intervention via web and individual health counseling. The intervention topics focus on stress management, healthy eating, and physical activity.
Goal-Oriented Episodic Future Thinking: Individuals in the intervention group will receive a 20-week web-based intervention and individual health coaching focused on stress management, healthy eating and physical activity.
|
Usual Prenatal Care
n=18 Participants
The usual prenatal care group will receive usual care from their providers
|
|---|---|---|
|
Change in Emotion Regulation
|
2.73 score on a scale
Standard Deviation 5.76
|
-1.53 score on a scale
Standard Deviation 6.26
|
SECONDARY outcome
Timeframe: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)Will be measured using The Perceived Stress Scale (10 items) that measures the degree to which situations in one's life are appraised as stressful. Values are: 0 - Never, 1 - Almost Never, 2 - Sometimes, 3 - Fairly Often, 4 - Very Often The investigators will sum 10 items to create a composite score, ranging from 0 to 40. The higher score, the higher levels of perceived stress.
Outcome measures
| Measure |
Goal-Oriented Episodic Future Thinking (GOEFT) Intervention
n=11 Participants
In addition to usual prenatal care, intervention participants will receive a 20-week intervention via web and individual health counseling. The intervention topics focus on stress management, healthy eating, and physical activity.
Goal-Oriented Episodic Future Thinking: Individuals in the intervention group will receive a 20-week web-based intervention and individual health coaching focused on stress management, healthy eating and physical activity.
|
Usual Prenatal Care
n=26 Participants
The usual prenatal care group will receive usual care from their providers
|
|---|---|---|
|
Change in Perceived Stress
|
1.73 score on a scale
Standard Deviation 6.12
|
2.04 score on a scale
Standard Deviation 5.39
|
SECONDARY outcome
Timeframe: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)Will be measured using The Perceived Stress Scale (10 items) that measures the degree to which situations in one's life are appraised as stressful. Values are: 0 - Never, 1 - Almost Never, 2 - Sometimes, 3 - Fairly Often, 4 - Very Often The investigators will sum 10 items to create a composite score, ranging from 0 to 40. The higher score, the higher levels of perceived stress.
Outcome measures
| Measure |
Goal-Oriented Episodic Future Thinking (GOEFT) Intervention
n=14 Participants
In addition to usual prenatal care, intervention participants will receive a 20-week intervention via web and individual health counseling. The intervention topics focus on stress management, healthy eating, and physical activity.
Goal-Oriented Episodic Future Thinking: Individuals in the intervention group will receive a 20-week web-based intervention and individual health coaching focused on stress management, healthy eating and physical activity.
|
Usual Prenatal Care
n=18 Participants
The usual prenatal care group will receive usual care from their providers
|
|---|---|---|
|
Change in Perceived Stress
|
-1.60 score on a scale
Standard Deviation 6.23
|
0.72 score on a scale
Standard Deviation 4.52
|
SECONDARY outcome
Timeframe: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)The Behavior Rating Inventory of Executive Function-Adults (75 items) was used to measure executive function. This survey asked participants to rate self-regulation behaviors in the everyday environment using a 3-point Likert scale ranging from 0 (never) to 2 (often). This survey covers 2 main domains: behavior regulation (30 items) and metacognition (45 items). We summed responses to the 30 behavior regulation items to create a behavior regulation score. Behavior regulation scores range from 0-60. We used the same approach to create a composite score for metacognition. Higher scores indicated worse behavior regulation or metacognition. The scores from T1 were compared to scores for T2 to evaluate the effect of the intervention.
Outcome measures
| Measure |
Goal-Oriented Episodic Future Thinking (GOEFT) Intervention
n=11 Participants
In addition to usual prenatal care, intervention participants will receive a 20-week intervention via web and individual health counseling. The intervention topics focus on stress management, healthy eating, and physical activity.
Goal-Oriented Episodic Future Thinking: Individuals in the intervention group will receive a 20-week web-based intervention and individual health coaching focused on stress management, healthy eating and physical activity.
|
Usual Prenatal Care
n=26 Participants
The usual prenatal care group will receive usual care from their providers
|
|---|---|---|
|
Change in Executive Function - Behavior Regulation
|
0.36 score on a scale
Standard Deviation 5.71
|
1.88 score on a scale
Standard Deviation 7.39
|
SECONDARY outcome
Timeframe: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)The Behavior Rating Inventory of Executive Function-Adults (75 items) was used to measure executive function. This survey asked participants to rate self-regulation behaviors in the everyday environment using a 3-point Likert scale ranging from 0 (never) to 2 (often). This survey covers 2 main domains: behavior regulation (30 items) and metacognition (45 items). We summed responses to the 30 behavior regulation items to create a behavior regulation score. Behavior regulation scores range from 0-60. We used the same approach to create a composite score for metacognition. Higher scores indicated worse behavior regulation or metacognition. The scores from T1 were compared to scores for T3 to evaluate the effect of the intervention.
Outcome measures
| Measure |
Goal-Oriented Episodic Future Thinking (GOEFT) Intervention
n=14 Participants
In addition to usual prenatal care, intervention participants will receive a 20-week intervention via web and individual health counseling. The intervention topics focus on stress management, healthy eating, and physical activity.
Goal-Oriented Episodic Future Thinking: Individuals in the intervention group will receive a 20-week web-based intervention and individual health coaching focused on stress management, healthy eating and physical activity.
|
Usual Prenatal Care
n=18 Participants
The usual prenatal care group will receive usual care from their providers
|
|---|---|---|
|
Change in Executive Function - Behavioral Regulation
|
-0.43 score on a scale
Standard Deviation 3.99
|
-0.17 score on a scale
Standard Deviation 5.22
|
SECONDARY outcome
Timeframe: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)The Behavior Rating Inventory of Executive Function-Adults (75 items) was used to measure executive function \[31\]. This survey asked participants to rate self-regulation behaviors in the everyday environment using a 3-point scale ranging from 0 (never) to 2 (often). This survey covers 2 main domains: behavior regulation (30 items) and metacognition (45 items). We summed responses to the 30 behavior regulation items to create a behavior regulation score. We used the same approach to create a composite score for metacognition. Metacognition scores range from 0-90. Higher scores indicated worse metacognition. The scores from T1 were compared to scores from T2 to evaluate the effect of the intervention.
Outcome measures
| Measure |
Goal-Oriented Episodic Future Thinking (GOEFT) Intervention
n=11 Participants
In addition to usual prenatal care, intervention participants will receive a 20-week intervention via web and individual health counseling. The intervention topics focus on stress management, healthy eating, and physical activity.
Goal-Oriented Episodic Future Thinking: Individuals in the intervention group will receive a 20-week web-based intervention and individual health coaching focused on stress management, healthy eating and physical activity.
|
Usual Prenatal Care
n=26 Participants
The usual prenatal care group will receive usual care from their providers
|
|---|---|---|
|
Change in Executive Function - Metacognition
|
-8.36 score on a scale
Standard Deviation 15.81
|
1.46 score on a scale
Standard Deviation 12.21
|
SECONDARY outcome
Timeframe: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)The Behavior Rating Inventory of Executive Function-Adults (75 items) was used to measure executive function \[31\]. This survey asked participants to rate self-regulation behaviors in the everyday environment using a 3-point scale ranging from 0 (never) to 2 (often). This survey covers 2 main domains: behavior regulation (30 items) and metacognition (45 items). We summed responses to the 30 behavior regulation items to create a behavior regulation score. We used the same approach to create a composite score for metacognition. Metacognition scores range from 0-90. Higher scores indicated worse metacognition. The scores from T1 were compared to scores from T3 to evaluate the effect of the intervention.
Outcome measures
| Measure |
Goal-Oriented Episodic Future Thinking (GOEFT) Intervention
n=14 Participants
In addition to usual prenatal care, intervention participants will receive a 20-week intervention via web and individual health counseling. The intervention topics focus on stress management, healthy eating, and physical activity.
Goal-Oriented Episodic Future Thinking: Individuals in the intervention group will receive a 20-week web-based intervention and individual health coaching focused on stress management, healthy eating and physical activity.
|
Usual Prenatal Care
n=18 Participants
The usual prenatal care group will receive usual care from their providers
|
|---|---|---|
|
Change in Executive Function - Metacognition
|
-5.86 score on a scale
Standard Deviation 11.37
|
-1.78 score on a scale
Standard Deviation 1.28
|
Adverse Events
Goal-Oriented Episodic Future Thinking (GOEFT) Intervention
Usual Prenatal Care
Serious adverse events
| Measure |
Goal-Oriented Episodic Future Thinking (GOEFT) Intervention
n=35 participants at risk
In addition to usual prenatal care, intervention participants will receive a 20-week intervention via web and individual health counseling. The intervention topics focus on stress management, healthy eating, and physical activity.
Goal-Oriented Episodic Future Thinking: Individuals in the intervention group will receive a 20-week web-based intervention and individual health coaching focused on stress management, healthy eating and physical activity.
|
Usual Prenatal Care
n=35 participants at risk
The usual prenatal care group will receive usual care from their providers
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Loss of Pregancy
|
2.9%
1/35 • Number of events 1 • 20 Week period of study
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Additional criteria for Serious Adverse event was loss of pregnancy
|
5.7%
2/35 • Number of events 2 • 20 Week period of study
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Additional criteria for Serious Adverse event was loss of pregnancy
|
Other adverse events
Adverse event data not reported
Additional Information
Mei-Wei Chang, PhD
Ohio State University College of Nursing
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place