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
Among 105 studies in Obesity by University of Colorado, Denver — 19 open to participants now, 32 under way, 2 of them phase 3. Obesity · University of Colorado, Denver.
Among the 105 studies in Obesity by University of Colorado, Denver, this one is the 51st largest by enrollment of the 88 interventional ones that give a count, is one of 11 that started in 2017, is one of 68 with no phase, and was the 46th registered.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
Browse Obesity studies →19 of the 105 studies in Obesity by University of Colorado, Denver are open now, in 1 country. Recruiting first, the newest first:
University of Colorado, Denver · Sites in United States
University of Colorado, Denver · Sites in United States
University of Colorado, Denver · Sites in United States
University of Colorado, Denver · Sites in United States
University of Colorado, Denver · Sites in United States
By country, each count listing its studies:
Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.
This study: 18 Years to 50 Years · female · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
105 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 8 · Phase 2 7 · Phase 3 4 · Phase 4 4
First in 2005; this study’s year is marked. 11 started in 2017.
This study's enrollment of 42 is below the median of 67 across 9,006 interventional studies indexed under Obesity.
Median enrollment 61 across the 88 interventional studies, 54 across the 17 observational. Of the 68 that completed or were terminated, 27 (40%) have results posted.
This tab as a report to print or save as PDF → With an account.
University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
11 of the studies in Obesity by University of Colorado, Denver that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06116435University of Colorado, DenverA Pilot Factorial Trial of an Integrated Lifestyle Intervention | 2026-12 |
| NCT06856928University of Colorado, DenverImpact of Antiobesity Medications on Appetite and Appetite-related Hormones and Metabolites. | 2026-12 |
| NCT04791371University of Colorado, DenverRole of Microvascular Insulin Resistance and Cardiorespiratory Fitness Diabetes | 2027-01-15 |
| NCT07446595University of Colorado, DenverBfedBwell INSPIRE Pilot | 2027-03 |
| NCT05870982University of Colorado, DenverEarly vs. Late Time Restricted Eating vs. Daily Caloric Restriction | 2027-03 |
Among the 105 studies in Obesity by University of Colorado, Denver, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 42 is below the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Weight Loss. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jul 2017 to primary completion in Feb 2018, 6 months.
Results were first posted in Mar 2020, 2 years after primary completion.
Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 6 months is below that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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University of Colorado, Denver →