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)
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.
Study Type
INTERVENTIONAL
Allocation
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.
The Ohio State University
Columbus, Ohio, United States
Percent Change in Body Weight
Data extracted from electronic medical record
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Percent Change in Body Weight
Data extracted from electronic medical record
Time frame: 24-27 week-gestation (T2) to 35-37 week-gestation (T3)
Percent Change in Body Weight
Data extracted from electronic medical record
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Percentage of Participants Diagnosed With Gestational Diabetes
Data extracted from electronic medical record. Percentage of participants who were diagnosed with Gestational Diabetes during the study timeframe.
Time frame: 24-27 week-gestation (T2) to 35-37 week-gestation (T3)
Percentage of Participants Diagnosed With Gestational Hypertension
Data extracted from electronic medical record. Percentage of participants diagnosed with Gestational Hypertension in the study timeframe.
Time frame: 24-27 week-gestation (T2) to 35-37 week-gestation (T3)
Percentage of Participants With Cesarean Delivery
Data extracted from electronic medical record. Percentage of participants who experienced Cesarean Delivery.
Time frame: 35-37 week-gestation (T3)
Newborn Body Weight
Data extracted from electronic medical record. Newborn Body Weight taken at birth.
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RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
70
Time frame: 35-37 week-gestation (T3)
Percentage of Participants With Premature (<37 Weeks Gestation) Births
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.
Time frame: 35-37 week-gestation (T3)
Percentage of Change in Dietary Intake Behaviors - Caloric Intake (Kcal)
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.
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Percentage of Change in Dietary Intake Behaviors - Fat (gm)
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.
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Percentage of Change in Dietary Intake Behaviors - Fruit (Cup)
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.
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Percentage of Change in Dietary Intake Behaviors - Vegetable (Cup)
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.
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Percentage of Change in Dietary Intake Behaviors - Added Sugars (Teaspoon or 4gm)
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.
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Percentage of Change in Dietary Intake Behaviors - Caloric Intake (Kcal)
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.
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Percentage of Change in Dietary Intake Behaviors - Fat Intake (gm)
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.
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Percentage of Change in Dietary Intake Behaviors - Fruit Intake (Cups)
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.
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Percentage of Change in Dietary Intake Behaviors - Vegetable Intake (Cups)
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.
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Percentage of Change in Dietary Intake Behaviors - Added Sugars Intake (gm)
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.
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Percentage of Change in Physical Activity - 7-Day Metabolic Equivalent of Task (MET)
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.
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Percentage of Change in Physical Activity - 7-Day Metabolic Equivalent of Task (MET)
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
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Change in Autonomous Motivation for Physical Activity
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.
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Change in Autonomous Motivation for Physical Activity
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.
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Change in Autonomous Motivation for Stress Management
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.
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Change in Autonomous Motivation for Stress Management
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.
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Change in Autonomous Motivation for Healthy Eating
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.
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Change in Autonomous Motivation for Healthy Eating
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
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Change in Healthy Eating Self-efficacy
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.
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Change in Healthy Eating Self-efficacy
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.
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Change in Coping Self-efficacy
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.
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Change in Coping Self-efficacy
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.
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Change in Physical Activity Self-efficacy
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.
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Change in Physical Activity Self-efficacy
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.
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Change in Emotion Regulation
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.
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Change in Emotion Regulation
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.
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Change in Perceived Stress
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.
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Change in Perceived Stress
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.
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Change in Executive Function - Behavior Regulation
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.
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Change in Executive Function - Behavioral Regulation
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.
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)
Change in Executive Function - Metacognition
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.
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 24-27 week-gestation (T2)
Change in Executive Function - Metacognition
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.
Time frame: Baseline: less than or equal to 16 week-gestation (T1) to 35-37 week-gestation (T3)