Using Mental Imagination to Prevent Excessive Gestational Weight Gain in Overweight and Obese Pregnant Women

Not Applicable

Completed

Conditions: Obesity
Weight Gain, Maternal

Interventions: Behavioral: Goal-Oriented Episodic Future Thinking

Registration Number: NCT04623008

Lead Sponsor: Ohio State University

Brief Summary: Moms Are Worth It is a lifestyle behavior intervention study aims to prevent excessive gestational weight gain in overweight or obese pregnant women through promotion of the stress management, healthy eating, and physical activity. Eligible women will be randomly assigned to a usual care or an intervention plus usual care group. The intervention will last 20 weeks and will be delivered via weekly web and individual health coaching session (10 of them)

Detailed Description: Current effective lifestyle behavior intervention studies aimed to prevent excessive gestational weight gain (EGWG) in overweight or obese pregnant women have limited practicality, scalability, and sustainability because of high participant burden and excessive cost for clinical practice. Also, prior studies paid little or no attention to motivation, emotion and cognition, all of which are critical to motivate and enable individuals to engage in healthy lifestyle behaviors and achieve positive health outcomes. A promising approach to prevent EGWG in overweight or obese pregnant women is through goal-oriented episodic future thinking (GOEFT). This pilot randomized controlled trial, aims to prevent EGWG in overweight or obese pregnant women. The proposed self-directed, web-based GOEFT intervention will focus on increasing motivation (autonomous motivation and self-efficacy) and improving emotion (emotion control and stress) and cognition (executive function, ExF), thus promoting healthy lifestyle behaviors. This will lead to prevention of EGWG and a reduced rate of gestational diabetes, gestational hypertension, cesarean delivery and fetal macrosomia. Our intervention will last 20 weeks (starting at 17 week-gestation). Participants (N = 90; 50% White, 50% minority) will be recruited and enrolled from prenatal care clinics at The Ohio State University Wexner Medical Center and be randomly assigned to our GOEFT intervention (n = 45) or usual care (n = 45). All participants will be assessed at baseline (\<17 week-gestation, T1), 24-27 week-gestation (T2) and 35-37 week-gestation (T3). Specific aims are (1) to determine feasibility of the GOEFT intervention: recruitment, randomization, retention and intervention implementation, (2) to investigate the potential efficacy of the intervention on gestational weight gain and maternal and birth outcomes, (3) to investigate the potential impact of the intervention on lifestyle behaviors and (4) to investigate the potential impact of the intervention on motivation, emotion and cognition.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 70

Inclusion Criteria

Participants must be pregnant women ≤ 13 week-gestation with a single fetus as assessed by ultrasound.
Participants must also have self-reported pre-pregnancy body mass index (BMI) of 25.0-45.0 kg/m2 and height (height and weight to compute body mass index).
Ability to read and speak English,
Age of 18-45 years,
Access to a working smart phone with unlimited text messaging,
Access to internet,
Receipt of prenatal care from our collaborating clinics and plan to deliver the baby at The Ohio State University (OSU) Wexner Medical Center,
Resident of Franklin Count,
Committed to the 20-week intervention.

Exclusion Criteria

Self-reported history of ≥ 3 miscarriages,
Planned termination of the pregnancy,
Diagnosed hypertension and/or type 1 or 2 diabetes,
History of or current diagnosis of an eating disorder,
Serious current physical disease (e.g., renal disease or cancer),
Past bariatric surgery,
Current or history of substance abuse in the past 6 months,
Current treatment for a serious psychological disorder (e.g., schizophrenia and bipolar disorder),
Contraindications to walking,
Consented women will become not eligible to participate in the study if they are not randomized by 16-week 6 days gestation. This is because the study intervention starts ≤ 17 weeks gestation.
Women will become not ineligible for participation if they did not complete the baseline data.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Goal-Oriented Episodic Future Thinking (GOEFT) Intervention	Goal-Oriented Episodic Future Thinking	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.

Primary Outcome Measures

Name	Time	Method
Percent Change in Body Weight	Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)	Data extracted from electronic medical record

Secondary Outcome Measures

Name	Time	Method
Change in Autonomous Motivation for Physical Activity	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.
Percentage of Participants Diagnosed With Gestational Diabetes	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.
Percentage of Participants Diagnosed With Gestational Hypertension	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.
Percentage of Participants With Cesarean Delivery	35-37 week-gestation (T3)	Data extracted from electronic medical record. Percentage of participants who experienced Cesarean Delivery.
Newborn Body Weight	35-37 week-gestation (T3)	Data extracted from electronic medical record. Newborn Body Weight taken at birth.
Percentage of Participants With Premature (<37 Weeks Gestation) Births	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.
Percentage of Change in Dietary Intake Behaviors - Caloric Intake (Kcal)	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.
Percentage of Change in Dietary Intake Behaviors - Fat (gm)	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.
Percentage of Change in Dietary Intake Behaviors - Fruit (Cup)	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.
Percentage of Change in Dietary Intake Behaviors - Vegetable (Cup)	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.
Percentage of Change in Dietary Intake Behaviors - Added Sugars (Teaspoon or 4gm)	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.
Percentage of Change in Dietary Intake Behaviors - Fat Intake (gm)	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.
Percentage of Change in Dietary Intake Behaviors - Fruit Intake (Cups)	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.
Percentage of Change in Dietary Intake Behaviors - Vegetable Intake (Cups)	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.
Percentage of Change in Dietary Intake Behaviors - Added Sugars Intake (gm)	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.
Percentage of Change in Physical Activity - 7-Day Metabolic Equivalent of Task (MET)	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
Change in Autonomous Motivation for Stress Management	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.
Change in Autonomous Motivation for Healthy Eating	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
Change in Healthy Eating Self-efficacy	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.
Change in Coping Self-efficacy	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.
Change in Physical Activity Self-efficacy	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.
Change in Emotion Regulation	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.
Change in Perceived Stress	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.
Change in Executive Function - Behavior Regulation	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.
Change in Executive Function - Behavioral Regulation	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.
Change in Executive Function - Metacognition	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.