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Weight Management in Mothers and Adult Daughters

Primary Purpose

Overweight or Obese

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Communication
Standard
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight or Obese

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of California San Diego

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Communication

Standard

Arm Description

Behavioral weight loss program with communication skills training

Standard behavioral weight loss program

Outcomes

Primary Outcome Measures

Weight change
Change in weight from baseline to post-intervention (16 weeks).

Secondary Outcome Measures

Anthropometrics
Blood pressure
Communication
Relationship factors (dyad, family, social networks)
Psychosocial factors
Eating behavior
Physical activity
Weight control behavior
Treatment attendance and adherence

Full Information

First Posted
February 22, 2016
Last Updated
October 11, 2021
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT02787902
Brief Title
Weight Management in Mothers and Adult Daughters
Official Title
Improving Communication and Collaboration for Weight Management in Mother-daughter
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight or Obese

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Communication
Arm Type
Experimental
Arm Description
Behavioral weight loss program with communication skills training
Arm Title
Standard
Arm Type
Active Comparator
Arm Description
Standard behavioral weight loss program
Intervention Type
Behavioral
Intervention Name(s)
Communication
Intervention Description
Behavioral weight management program adapted for mother-daughter dyads with communication skills training
Intervention Type
Behavioral
Intervention Name(s)
Standard
Intervention Description
Behavioral weight management program adapted for mother-daughter dyads without communication skills training
Primary Outcome Measure Information:
Title
Weight change
Description
Change in weight from baseline to post-intervention (16 weeks).
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Anthropometrics
Time Frame
baseline and post-intervention (16 weeks)
Title
Blood pressure
Time Frame
baseline and post-intervention (16 weeks)
Title
Communication
Time Frame
baseline and post-intervention (16 weeks)
Title
Relationship factors (dyad, family, social networks)
Time Frame
baseline and post-intervention (16 weeks)
Title
Psychosocial factors
Time Frame
baseline and post-intervention (16 weeks)
Title
Eating behavior
Time Frame
baseline and post-intervention (16 weeks)
Title
Physical activity
Time Frame
baseline and post-intervention (16 weeks)
Title
Weight control behavior
Time Frame
baseline and post-intervention (16 weeks)
Title
Treatment attendance and adherence
Time Frame
between baseline and post-intervention (16 weeks)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
93093
Country
United States

12. IPD Sharing Statement

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Weight Management in Mothers and Adult Daughters

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