An interventional study of Observation Group participants and Lifestyle group participants in Weight Loss, Diet Modification and Obesity, sponsored by University of Colorado, Denver. Completed at 2 sites in United States. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-20.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Supportive care
Low-income and minority women are at increased risk for postpartum weight retention (i.e. retaining weight after pregnancy) and consequent persistent obesity. Women who are obese pre-pregnancy are 3-5 times more likely to gain weight, rather than lose weight, in the postpartum period than non-obese women. Aims for this pilot study are listed below:
Aim 1: To evaluate the feasibility and acceptability of a multi-component novel weight loss intervention delivered in a WIC setting to a population of low-income, predominantly racial/ethnic minority, obese, postpartum women.
Aim 2: To evaluate differences in weight change, diet, physical activity, self-efficacy, readiness to change, motivations to eat between intervention and control participants to determine preliminary intervention efficacy over a 12-week period.
Low-income and minority women are at increased risk for postpartum weight retention (i.e. retaining weight after pregnancy) and consequent persistent obesity. Women who are obese pre-pregnancy are 3-5 times more likely to gain weight, rather than lose weight, in the postpartum period than non-obese women.
Obesity science supports that weight loss interventions should be multi-component with regular points of contact. Building upon this, we have designed a multi-component intervention that considers the demands on women in the postpartum period and utilizes technology for both provider decision support and for virtual contact with participants. The intervention will address diet, physical activity, and social support through the use of in-person meetings with WIC staff, text messaging, phone coaching, self-monitoring, and Facebook.
Exclusion Criteria:
Intervention: Participants will receive usual WIC care plus they will be given a packet of written WIC materials on lifestyle recommendations at the baseline visit, and offered an appointment with a WIC Registered Dietitian (RD) at the 12 week visit.
Behavioral: Observation Group participants
Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants. In-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff.
Behavioral: Lifestyle group participants
Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time.
Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.
Feasibility of Recruitment
The investigators plan to determine the feasibility of recruitment for a weight loss intervention by evaluating the rate of recruitment. Below describes number recruited/enrolled over 14 weeks of recruitment
Time frame: Once the final participant is recruited
Attrition Rate of Subjects Enrolled in the Study
The investigators will measure the number of dropouts/withdrawn once final participant has completed the 12 week visit.
Time frame: Once the final participant completes the 12 week visit
Visit Attendance
The investigators will measure lifestyle group participant attendance from enrollment through the 12-week visit. The number of participants who attended their visits is reported
Time frame: Baseline through Week 12, reported at Week 12
Acceptability of a Weight Loss Intervention
To determine acceptability, investigators will use qualitative interviews to ask open-ended questions on this topic including asking participants in the intervention whether they would participate again. The number of participants interviewed who indicated that they would participate again is reported.
Time frame: 12 weeks
Evaluation of the Use of Phone Coaching
Investigators will count the total number of times any participant used phone coaching.
Time frame: 12 weeks
Change in Weight Between Visits
To determine differences in change in weight between the intervention and control groups, participants will be weighed on a scale in the Women, Infants, and Children (WIC) setting.
Time frame: Intervention group: Baseline, 12 weeks; Control group: Baseline and 12 weeks
Changes in Diet: Intakes Measured in Grams
To determine differences in diet from baseline to 12 weeks between intervention and control groups, participants will complete the Block Fat-Sugar-Fruit-Vegetable Screener. This is a validated food screener for adults.
Time frame: Baseline and 12 weeks
Changes in Physical Activity
To determine differences in total physical activity from baseline to 12 weeks between intervention and control groups, participants will complete an adapted version of the Pregnancy Physical Activity Questionnaire. This is a validated survey measure for physical activity.
Time frame: Baseline and 12 weeks
Changes in Diet and Physical Activity Self-efficacy
To determine differences in self-efficacy from baseline to 12 weeks between intervention and control groups, participants will complete an adapted version of Eating Habits Confidence Survey and Exercise Confidence Survey. Diet self-efficacy: Possible range: -32 to 32; Higher scores indicate improved self-efficacy. Physical activity self-efficacy: Sticking to it scale: Possible range: -32 to 32; Higher scores indicate improved self-efficacy. Making time scale: -12 to 12; Higher scores indicate improved self-efficacy.
Time frame: Baseline and 12 weeks
Changes in Motivations to Eat
To determine differences from baseline to12 weeks in motivations to eat between intervention and control groups, participants will complete the Eating Stimulus Index questionnaire. Possible range = -92 to 92. Higher scores indicated improved lifestyle-related behaviors and motivations to eat.
Time frame: Baseline and 12 weeks
Changes in Readiness to Change
Investigators will evaluate any differences in readiness to change from baseline to 12 weeks between intervention and control groups by participants completing the Readiness to Change questionnaire. Possible range = -3 to 3; higher scores indicate greater change in readiness to change
Time frame: Baseline and 12 weeks
Changes in Diet: Intakes Measured in Cups
To determine differences in diet from baseline to 12 weeks between intervention and control groups, participants will complete the Block Fat-Sugar-Fruit-Vegetable Screener. This is a validated food screener for adults. Fruit and vegetable intake changes are measured and reported in cups.
Time frame: Baseline and 12 weeks
Changes in Diet: kCal Intake
To determine differences in diet from baseline to 12 weeks between intervention and control groups, participants will complete the Block Fat-Sugar-Fruit-Vegetable Screener. This is a validated food screener for adults.
Time frame: Baseline and 12 weeks
| Milestone | Observational Group | Lifestyle Group |
|---|---|---|
| Started | 22 | 20 |
| Completed | 22 | 15 |
| Not completed | 0 | 5 |
| Withdrew: Lost to follow-up | 0 | 3 |
| Withdrew: Withdrawn | 0 | 1 |
| Withdrew: Noted not eligible right after enrolled | 0 | 1 |
The investigators plan to determine the feasibility of recruitment for a weight loss intervention by evaluating the rate of recruitment. Below describes number recruited/enrolled over 14 weeks of recruitment
| participants | Observational Group | Lifestyle Group |
|---|---|---|
| Feasibility of Recruitment | 22 | 19 |
The investigators will measure the number of dropouts/withdrawn once final participant has completed the 12 week visit.
| Participants | Observational Group | Lifestyle Group |
|---|---|---|
| Attrition Rate of Subjects Enrolled in the Study | 0 | 4 |
The investigators will measure lifestyle group participant attendance from enrollment through the 12-week visit. The number of participants who attended their visits is reported
| Participants | Lifestyle Group |
|---|---|
| Attended all 4 visits (Baseline, 4 week visit, 8 | 7 |
| Attended 3 of 4 visits (Baseline, 4 or 8 week visi | 5 |
| Attended 2 of 4 visits (baseline and 12 week visi | 3 |
| Attended 0 intervention visits | 3 |
To determine acceptability, investigators will use qualitative interviews to ask open-ended questions on this topic including asking participants in the intervention whether they would participate again. The number of participants interviewed who indicated that they would participate again is reported.
| Participants | Lifestyle Group |
|---|---|
| Acceptability of a Weight Loss Intervention | 14 |
Investigators will count the total number of times any participant used phone coaching.
| Number of phone coaching sessions | Lifestyle Group |
|---|---|
| Evaluation of the Use of Phone Coaching | 1 |
To determine differences in change in weight between the intervention and control groups, participants will be weighed on a scale in the Women, Infants, and Children (WIC) setting.
| pounds | Observational Group | Lifestyle Group |
|---|---|---|
| Change in Weight Between Visits | -0.8 ± 6.4 | -4.7 ± 7.5 |
To determine differences in diet from baseline to 12 weeks between intervention and control groups, participants will complete the Block Fat-Sugar-Fruit-Vegetable Screener. This is a validated food screener for adults.
| Grams | Observational Group | Lifestyle Group |
|---|---|---|
| Saturated fat (g) | -3.7 ± 8.1 | -4.1 ± 5.7 |
| Trans fat (g) | 0.2 ± 3.5 | -1.2 ± 2.7 |
| Total sugars (g) | -35.1 ± 50.4 | -25.2 ± 34 |
| Added sugars (g) | -25.7 ± 39.5 | -23.3 ± 33.6 |
| protein (g) | -10.2 ± 22.2 | -6.3 ± 25.5 |
| total fat (g) | -9.9 ± 24.5 | -9.4 ± 16.4 |
| carbohydrates (g) | -40.9 ± 79.8 | -46.7 ± 48.8 |
| fiber (g) | 0.1 ± 4.8 | -0.4 ± 3.1 |
To determine differences in total physical activity from baseline to 12 weeks between intervention and control groups, participants will complete an adapted version of the Pregnancy Physical Activity Questionnaire. This is a validated survey measure for physical activity.
| MET-h/week | Observational Group | Lifestyle Group |
|---|---|---|
| Changes in Physical Activity | -45.5 ± 176 | 38.6 ± 126 |
To determine differences in self-efficacy from baseline to 12 weeks between intervention and control groups, participants will complete an adapted version of Eating Habits Confidence Survey and Exercise Confidence Survey. Diet self-efficacy: Possible range: -32 to 32; Higher scores indicate improved self-efficacy. Physical activity self-efficacy: Sticking to it scale: Possible range: -32 to 32; Higher scores indicate improved self-efficacy. Making time scale: -12 to 12; Higher scores indicate improved self-efficacy.
| units on a scale | Observational Group | Lifestyle Group |
|---|---|---|
| Physical activity: Sticking to it | -0.5 ± 0.9 | 0.4 ± 1.0 |
| Physical activity: making time for exercise | -0.3 ± 1.0 | 0.0 ± 0.8 |
| Diet | 3.3 ± 3.1 | -0.1 ± 7.2 |
To determine differences from baseline to12 weeks in motivations to eat between intervention and control groups, participants will complete the Eating Stimulus Index questionnaire. Possible range = -92 to 92. Higher scores indicated improved lifestyle-related behaviors and motivations to eat.
| units on a scale | Observational Group | Lifestyle Group |
|---|---|---|
| Changes in Motivations to Eat | -3.3 ± 9.6 | 5.9 ± 12.0 |
Investigators will evaluate any differences in readiness to change from baseline to 12 weeks between intervention and control groups by participants completing the Readiness to Change questionnaire. Possible range = -3 to 3; higher scores indicate greater change in readiness to change
| units on a scale | Observational Group | Lifestyle Group |
|---|---|---|
| Losing weight | 0 (0 to 1) | 1.0 (0 to 1) |
| Healthy eating | 0 (0 to 1) | 1.0 (0 to 1) |
| Physical activity | 0 (-1 to 1) | 1.0 (0 to 2) |
To determine differences in diet from baseline to 12 weeks between intervention and control groups, participants will complete the Block Fat-Sugar-Fruit-Vegetable Screener. This is a validated food screener for adults. Fruit and vegetable intake changes are measured and reported in cups.
| Cups | Observational Group | Lifestyle Group |
|---|---|---|
| Fruit and fruit juice (cups) | -0.2 ± 1.5 | 0 ± 1.4 |
| vegetable intake (cups) | -0.1 ± 0.9 | 0.3 ± 0.9 |
To determine differences in diet from baseline to 12 weeks between intervention and control groups, participants will complete the Block Fat-Sugar-Fruit-Vegetable Screener. This is a validated food screener for adults.
| kcal | Observational Group | Lifestyle Group |
|---|---|---|
| Changes in Diet: kCal Intake | -294 ± 531.7 | -297 ± 374.7 |
Collected over 12 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Observational Group | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) |
| Lifestyle Group | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
| Age, Continuous(years) | Observational Group | Lifestyle Group | Total |
|---|---|---|---|
| Mean | 31.2 ± 6.6 | 30.5 ± 5.0 | 30.9 ± 5.8 |
| Sex: Female, Male(Participants) | Observational Group | Lifestyle Group | Total |
|---|---|---|---|
| Female | 22 | 19 | 41 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Observational Group | Lifestyle Group | Total |
|---|---|---|---|
| Hispanic | 20 | 17 | 37 |
| African American, non-Hispanic | 1 | 2 | 3 |
| White, non-Hispanic | 1 | 0 | 1 |
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University of Colorado, Denver