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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR002535 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Colorado Clinical & Translational Sciences Institute | OTHER |
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational Group | Experimental | 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. |
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| Lifestyle Group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observation Group participants | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 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 | 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. | 12 weeks |
| Evaluation of the Use of Phone Coaching | Investigators will count the total number of times any participant used phone coaching. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Intervention group: Baseline, 12 weeks; Control group: Baseline and 12 weeks |
| Changes in Diet: Intakes Measured in Grams |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Darcy A Thompson, MD, MPH | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aurora WIC Office | Aurora | Colorado | 80011 | United States | ||
| University of Colorado |
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| ID | Title | Description |
|---|---|---|
| FG000 | Observational Group | 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. Observation 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. |
| FG001 | Lifestyle Group | 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. Lifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Observational Group | 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. Observation 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | One participant was consented but determined before receiving any interventions that they did not meet all eligibility criteria. This participant is excluded from the lifestyle group. | Posted | Number | participants | Once the final participant is recruited |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Observational Group | 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. Observation 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Darcy Thompson, Associate Professor | University of Colorado | 303 724 7471 | darcy.thompson@ucdenver.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 8, 2017 | May 31, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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This is a pilot, randomized controlled trial. The investigators will pilot a multi-component intervention delivered in a WIC (Women, Infants, children) setting.
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| Lifestyle group participants | Behavioral | Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks. |
|
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. |
| 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. | 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. | 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. | 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 | 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. | 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. | Baseline and 12 weeks |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Noted not eligible right after enrolled |
|
| BG001 | Lifestyle Group | 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. Lifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| OG001 | Lifestyle Group | 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. Lifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks. |
|
|
| Primary | 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. | The 1 participant originally enrolled, but removed right after enrollment because was determined not eligible is not included in the Lifestyle group count. | Posted | Count of Participants | Participants | Once the final participant completes the 12 week visit |
|
|
|
| Primary | 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 | 2 participants are excluded from analysis: Participant who was withdrawn was not included in analysis. Participant identified as not eligible right after enrollment is not included either. | Posted | Count of Participants | Participants | Baseline through Week 12, reported at Week 12 |
|
|
|
| Primary | 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. | Data was not available for analysis for one participant. This participant was not analyzed. The three participants lost to follow-up before the baseline visit were not available for interview and are excluded. | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Primary | Evaluation of the Use of Phone Coaching | Investigators will count the total number of times any participant used phone coaching. | Posted | Number | Number of phone coaching sessions | 12 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | pounds | Intervention group: Baseline, 12 weeks; Control group: Baseline and 12 weeks |
|
|
|
|
| Secondary | 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. | Data missing for one Lifestyle Group participant at the 12 week point | Posted | Mean | Standard Deviation | Grams | Baseline and 12 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | MET-h/week | Baseline and 12 weeks |
|
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|
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| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 weeks |
|
|
|
|
| Secondary | 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 | Posted | Mean | Inter-Quartile Range | units on a scale | Baseline and 12 weeks |
|
|
|
| Secondary | 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. | Data missing for one Lifestyle Group participant at the 12 week point | Posted | Mean | Standard Deviation | Cups | Baseline and 12 weeks |
|
|
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| Secondary | 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. | Data missing for one Lifestyle Group participant at the 12 week point | Posted | Mean | Standard Deviation | kcal | Baseline and 12 weeks |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Lifestyle Group | 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. Lifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks. | 0 | 19 | 0 | 19 | 0 | 19 |
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| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| Attended 0 intervention visits |
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