Overweight or Obese Clinical Trial
Official title:
Improving Communication and Collaboration for Weight Management in Mother-daughter
| NCT number | NCT02787902 |
| Other study ID # | 151345 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | August 1, 2018 |
| Est. completion date | December 31, 2020 |
| Verified date | October 2021 |
| Source | University of California, San Diego |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to develop, implement, and evaluate a behavioral weight management intervention with a communication training component for Mexican-American women. The study has three specific aims. Aim 1: Develop a behavioral weight loss intervention that modifies evidence-based behavioral weight loss treatment using results from formative data collected from Mexican-American mother-daughter dyads. The adapted intervention will focus on improving dyadic communication and collaboration for providing reciprocal support for healthy eating and physical activity behaviors. Aim 2: Implement and evaluate a pilot weight management program adapted for mother-daughter dyads. Dyads will be randomly assigned to partner-based treatment with or without communication skills training. Aim 3: Evaluate associations between changes in weight, weight-related behaviors, and psychosocial variables with changes in measures assessing interpersonal communication.
| Status | Completed |
| Enrollment | 54 |
| Est. completion date | December 31, 2020 |
| Est. primary completion date | December 31, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 65 Years |
| Eligibility | Inclusion Criteria: - Female - Body mass index of 25-50 kg/m2 - Mexican or Mexican-American Exclusion Criteria: - Pregnancy or plans to become pregnant in the next year - 5% weight loss in the last 3 months - History of bariatric surgery - Serious medical condition or psychological disorder |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of California San Diego | La Jolla | California |
| Lead Sponsor | Collaborator |
|---|---|
| University of California, San Diego |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Weight change | Change in weight from baseline to post-intervention (16 weeks). | 16 weeks | |
| Secondary | Anthropometrics | baseline and post-intervention (16 weeks) | ||
| Secondary | Blood pressure | baseline and post-intervention (16 weeks) | ||
| Secondary | Communication | baseline and post-intervention (16 weeks) | ||
| Secondary | Relationship factors (dyad, family, social networks) | baseline and post-intervention (16 weeks) | ||
| Secondary | Psychosocial factors | baseline and post-intervention (16 weeks) | ||
| Secondary | Eating behavior | baseline and post-intervention (16 weeks) | ||
| Secondary | Physical activity | baseline and post-intervention (16 weeks) | ||
| Secondary | Weight control behavior | baseline and post-intervention (16 weeks) | ||
| Secondary | Treatment attendance and adherence | between baseline and post-intervention (16 weeks) |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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