- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02787902
Weight Management in Mothers and Adult Daughters
Improving Communication and Collaboration for Weight Management in Mother-daughter
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
La Jolla, California, United States, 93093
- University of California San Diego
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Communication
Behavioral weight loss program with communication skills training
|
Behavioral weight management program adapted for mother-daughter dyads with communication skills training
|
|
Active Comparator: Standard
Standard behavioral weight loss program
|
Behavioral weight management program adapted for mother-daughter dyads without communication skills training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight change
Time Frame: 16 weeks
|
Change in weight from baseline to post-intervention (16 weeks).
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Anthropometrics
Time Frame: baseline and post-intervention (16 weeks)
|
baseline and post-intervention (16 weeks)
|
|
Blood pressure
Time Frame: baseline and post-intervention (16 weeks)
|
baseline and post-intervention (16 weeks)
|
|
Communication
Time Frame: baseline and post-intervention (16 weeks)
|
baseline and post-intervention (16 weeks)
|
|
Relationship factors (dyad, family, social networks)
Time Frame: baseline and post-intervention (16 weeks)
|
baseline and post-intervention (16 weeks)
|
|
Psychosocial factors
Time Frame: baseline and post-intervention (16 weeks)
|
baseline and post-intervention (16 weeks)
|
|
Eating behavior
Time Frame: baseline and post-intervention (16 weeks)
|
baseline and post-intervention (16 weeks)
|
|
Physical activity
Time Frame: baseline and post-intervention (16 weeks)
|
baseline and post-intervention (16 weeks)
|
|
Weight control behavior
Time Frame: baseline and post-intervention (16 weeks)
|
baseline and post-intervention (16 weeks)
|
|
Treatment attendance and adherence
Time Frame: between baseline and post-intervention (16 weeks)
|
between baseline and post-intervention (16 weeks)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 151345
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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