Reducing Maternal Stress to Improve Obesity-related Parenting Practices

NCT05032430 | Active Not Recruiting

• 2 other identifiers: IRB-220-317K23AT011049
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Participant Satisfaction with Intervention Assessed by the Client Satisfaction Questionnaire

  Parents will be asked to complete a brief, 8-item, widely used measure of satisfaction with health-related services, available in Spanish and English. Scores range from 8 to 32, with higher values indicating higher satisfaction.

  Immediately after the intervention

• Participant Retention

  Research staff will take attendance during each intervention session.

  At the beginning of each of the 6 weekly intervention sessions

Secondary Outcomes (6)

• Change in the Five Facet Mindfulness Questionnaire

  Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline

• Change in the Perceived Stress Scale

  Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline

• Change in the Child Feeding Questionnaire

  Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline

• Change in the Frequency of Family Eating and Exercise Behaviors Questionnaire

  Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline

• Change in height in meters

  Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline

Other Outcomes (6)

• Change in Child Daily Kilocalories via 3-Day Food Record

  Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline

• Change in Child Frequency of Physical Activity as Assessed by the Physical Activity Recall Screen

  Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline

• Change in Child Quality of Life as Assessed by the Pediatric Health-Related Quality of Life Questionnaire

  Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline

Study Arms (2)

Calma, Conversa, y Cría (CCC)

EXPERIMENTAL

Mindfulness-based parental stress reduction intervention

Behavioral: CCC

Enhanced Usual Care

ACTIVE COMPARATOR

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

Behavioral: Enhanced Usual Care

Interventions

CCC BEHAVIORAL

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

Calma, Conversa, y Cría (CCC)

Enhanced Usual Care 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.

Enhanced Usual Care

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• American University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• Virginia Commonwealth University: collaborator
• George Washington University: collaborator
• Johns Hopkins University: collaborator

Study Sites (1)

American University

Washington D.C., District of Columbia, 20016, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: September 2, 2021
• Study Start: April 25, 2023
• Primary Completion: January 14, 2025
• Study Completion: March 14, 2025
• Last Updated: June 20, 2024

Record last verified: 2024-06

Locations

US (1)