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Weight Management in Mothers and Adult Daughters

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02787902
Recruitment Status : Suspended (Trial suspended due to COVID-19.)
First Posted : June 1, 2016
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Becky Marquez, University of California, San Diego

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.


Condition or disease Intervention/treatment Phase
Overweight or Obese Behavioral: Communication Behavioral: Standard Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Communication and Collaboration for Weight Management in Mother-daughter
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Experimental: Communication
Behavioral weight loss program with communication skills training
Behavioral: Communication
Behavioral weight management program adapted for mother-daughter dyads with communication skills training

Active Comparator: Standard
Standard behavioral weight loss program
Behavioral: Standard
Behavioral weight management program adapted for mother-daughter dyads without communication skills training




Primary Outcome Measures :
  1. Weight change [ Time Frame: 16 weeks ]
    Change in weight from baseline to post-intervention (16 weeks).


Secondary Outcome Measures :
  1. Anthropometrics [ Time Frame: baseline and post-intervention (16 weeks) ]
  2. Blood pressure [ Time Frame: baseline and post-intervention (16 weeks) ]
  3. Communication [ Time Frame: baseline and post-intervention (16 weeks) ]
  4. Relationship factors (dyad, family, social networks) [ Time Frame: baseline and post-intervention (16 weeks) ]
  5. Psychosocial factors [ Time Frame: baseline and post-intervention (16 weeks) ]
  6. Eating behavior [ Time Frame: baseline and post-intervention (16 weeks) ]
  7. Physical activity [ Time Frame: baseline and post-intervention (16 weeks) ]
  8. Weight control behavior [ Time Frame: baseline and post-intervention (16 weeks) ]
  9. Treatment attendance and adherence [ Time Frame: between baseline and post-intervention (16 weeks) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02787902


Locations
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United States, California
University of California San Diego
La Jolla, California, United States, 93093
Sponsors and Collaborators
University of California, San Diego
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Responsible Party: Becky Marquez, Assistant Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02787902    
Other Study ID Numbers: 151345
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Overweight
Body Weight