NCT02787902

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 1, 2016

Completed
2.2 years until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

October 12, 2021

Status Verified

October 1, 2021

Enrollment Period

2.4 years

First QC Date

February 22, 2016

Last Update Submit

October 11, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Weight change

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

    16 weeks

Secondary Outcomes (9)

  • Anthropometrics

    baseline and post-intervention (16 weeks)

  • Blood pressure

    baseline and post-intervention (16 weeks)

  • Communication

    baseline and post-intervention (16 weeks)

  • Relationship factors (dyad, family, social networks)

    baseline and post-intervention (16 weeks)

  • Psychosocial factors

    baseline and post-intervention (16 weeks)

  • +4 more secondary outcomes

Study Arms (2)

Communication

EXPERIMENTAL

Behavioral weight loss program with communication skills training

Behavioral: Communication

Standard

ACTIVE COMPARATOR

Standard behavioral weight loss program

Behavioral: Standard

Interventions

CommunicationBEHAVIORAL

Behavioral weight management program adapted for mother-daughter dyads with communication skills training

Communication
StandardBEHAVIORAL

Behavioral weight management program adapted for mother-daughter dyads without communication skills training

Standard

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female
  • Body mass index of 25-50 kg/m2
  • Mexican or Mexican-American

You may not qualify if:

  • Pregnancy or plans to become pregnant in the next year
  • % weight loss in the last 3 months
  • History of bariatric surgery
  • Serious medical condition or psychological disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Diego

La Jolla, California, 93093, United States

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 22, 2016

First Posted

June 1, 2016

Study Start

August 1, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

October 12, 2021

Record last verified: 2021-10

Locations