NCT05120804

Brief Summary

Mexican American families share similar elevated risks for obesity and obesity-related conditions, such as type 2 diabetes. Because negative family interactions and relationships (e.g., poor communication, high conflict, low emotional closeness) are associated with obesity treatment outcomes, this study tests a behavioral weight management intervention that provides relationship skills counseling to mothers and adult daughters. The goal is to improve family interaction patterns to buffer challenges and strengthen collaboration for eating and physical activity behaviors that support long-term weight management and thus provide an effective obesity treatment approach to address a major public health concern.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
236

participants targeted

Target at P75+ for not_applicable obesity

Timeline
3mo left

Started Feb 2022

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

2 active sites

Status
active not recruiting

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

Study Progress94%
Feb 2022Aug 2026

First Submitted

Initial submission to the registry

October 11, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 15, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

February 22, 2022

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

4.5 years

First QC Date

October 11, 2021

Last Update Submit

February 10, 2026

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Weight change

    Weight loss

    baseline to 6 month post-intervention

Secondary Outcomes (7)

  • Weight change

    6 month post-intervention to 12 month follow-up

  • Anthropometric measurement

    baseline to 6 month post-intervention and 12 month follow-up

  • Hemoglobin A1C

    baseline to 6 month post-intervention and 12 month follow-up

  • Family functioning

    baseline to 6 month post-intervention and 12 month follow-up

  • Eating behavior

    baseline to 6 month post-intervention and 12 month follow-up

  • +2 more secondary outcomes

Study Arms (2)

Standard behavioral treatment

ACTIVE COMPARATOR

Nutrition and physical activity education along with behavior modification techniques

Behavioral: Standard behavioral treatment

Standard behavioral treatment plus relationship skills training

EXPERIMENTAL

Nutrition and physical activity education along with behavior modification techniques plus brief and structured counseling on family functioning

Behavioral: Standard behavioral treatment plus relationship skills training

Interventions

Standard behavioral treatmentBEHAVIORAL

Nutrition and physical activity education along with behavior modification techniques

Also known as: SBT
Standard behavioral treatment
Standard behavioral treatment plus relationship skills trainingBEHAVIORAL

Nutrition and physical activity education along with behavior modification techniques plus relationship skills training

Also known as: SBTR
Standard behavioral treatment plus relationship skills training

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSelf-identify as female
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female
  • years of age
  • Mexican or Mexican American
  • Reside in San Diego County
  • Body mass index of 25-45 kg/m2

You may not qualify if:

  • Unable to read and write in English or Spanish
  • Pregnant or plan to become pregnant in the next year
  • Have a physical limitation that makes exercise like walking difficult
  • Currently participating in a weight loss program
  • Underwent weight loss surgery
  • Report a serious medical or psychological condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California San Diego

La Jolla, California, 92037, United States

Location

University of California San Diego

La Jolla, California, 93093, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition 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
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 11, 2021

First Posted

November 15, 2021

Study Start

February 22, 2022

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

February 11, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(2)