Reducing Maternal Stress to Improve Obesity-related Parenting Practices

NCT ID: NCT05032430

Last Updated: 2024-06-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-25
• Study Completion Date: 2025-03-14

Brief Summary

Maternal stress is associated with children's risk for obesity controlling for socioeconomic status. The association between maternal stress and child obesity is particularly strong in Latinx families, whose children also have the highest rates of obesity in the United States. A mindful parenting program might reduce Latina mothers' psychological stress and lead to improved parenting practices and ability to create a healthier environment. The primary objective of the proposed research is to evaluate the feasibility and acceptability of a culturally-relevant intervention that integrates mindfulness-based stress reduction and mindful parenting in Latina mothers. The investigators will conduct a randomized clinical trial comparing the Calma, Conversa, y Cría (CCC) intervention to an active control condition in 50 Latina mothers of elementary-school age children. Participant satisfaction rates and qualitative interviews will provide evidence of the program's acceptability. Feasibility will be determined by examining recruitment rates, retention rates, and treatment fidelity. Completion of this project will inform the development of a full-scale efficacy trial.

Conditions

Obesity, Childhood

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Calma, Conversa, y Cría (CCC)

Mindfulness-based parental stress reduction intervention

Group Type: EXPERIMENTAL

CCC

Intervention Type: BEHAVIORAL

A mix of mindfulness-based stress reduction, mindful eating, and mindful parenting strategies.

Enhanced Usual Care

Comparator group designed to influence health and well-being that does not include mindfulness as an active ingredient.

Group Type: ACTIVE_COMPARATOR

Enhanced Usual Care

Intervention Type: BEHAVIORAL

Consists of strategies meant to enhance health and well-being (e.g., health education, strategies to get more physical activity) but does not include mindfulness as an active ingredient.

Interventions

CCC

A mix of mindfulness-based stress reduction, mindful eating, and mindful parenting strategies.

Intervention Type: BEHAVIORAL

Enhanced Usual Care

Consists of strategies meant to enhance health and well-being (e.g., health education, strategies to get more physical activity) but does not include mindfulness as an active ingredient.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• over the age of 18 years
• identify as female
• identify as Hispanic or Latina
• have a child between the ages of 3 and 11 years who primarily resides with them
• able to understand basic instructions in either Spanish or English

Exclusion Criteria

• pregnant or planning on becoming pregnant in the near future
• actively dependent on a substance
• have untreated psychosis, PTSD, or social anxiety that would impair their ability to function in a group setting
• child has an obesity-associated genetic syndrome
• child has a pervasive developmental disorder

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: collaborator

George Washington University

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: collaborator

American University

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Cotter

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

American University

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

K23AT011049

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-220-317

Identifier Type: -

Identifier Source: org_study_id