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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date October 2021
Source University of California, San Diego
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Communication
Behavioral weight management program adapted for mother-daughter dyads with communication skills training
Standard
Behavioral weight management program adapted for mother-daughter dyads without communication skills training

Locations

Country Name City State
United States University of California San Diego La Jolla California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

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)
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