Reducing Maternal Stress to Improve Obesity-related Parenting Practices

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity, Childhood
• Intervention / Treatment: Behavioral: Enhanced Usual Care; Behavioral: CCC

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20016
      • American University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Enhanced Usual Care; Comparator group designed to influence health and well-being that does not include mindfulness as an active ingredient.	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.
Experimental: Calma, Conversa, y Cría (CCC); Mindfulness-based parental stress reduction intervention	Behavioral: CCC; A mix of mindfulness-based stress reduction, mindful eating, and mindful parenting strategies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Five Facet Mindfulness Questionnaire	The Five Facet Mindfulness Questionnaire (Spanish version) is a 39-item self-report measure of five facets of mindfulness: observing, describing, acting with awareness, non-judgment, and non-reactivity. Scores range from 39 to 190 with higher scores suggesting greater mindfulness.	Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline
Change in the Perceived Stress Scale	The Perceived Stress Scale is a 10-item, widely used self-report measure of perceptions of psychological stress. Scores range from 0 to 40 with higher scores indicating greater perceived stress.	Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline
Change in the Child Feeding Questionnaire	The Child Feeding Questionnaire is a 31-item self-report questionnaire that assesses parents' beliefs, attitudes, and approaches toward feeding their children. Scores range from 31 to 155 with higher scores representing greater use of controlling feeding practices.	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	28 items used in previous work by Neumark-Sztainer et al. will be used to assess eating and weight-related habits of families. Items assess: frequency of family meals, fast food consumption, and watching TV during meals; availability of fruits and vegetables and sugar sweetened beverages; and parents' encouragement of healthy food consumption and physical activity.	Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline
Change in height in meters	Height will be measured to the nearest 0.1cm using a precision stadiometer.	Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline
Change in weight in kilograms	Weight will be measured to the nearest 0.1kg using a digital scale.	Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Child Daily Kilocalories via 3-Day Food Record	Participants will be trained to complete a 3-day food record (using a detailed food record form) to track dietary intake for 2 weekdays and 1 weekend day in the week prior to their assessment. Diet will be analyzed via Nutrition Data System Software (NDSR). Average kilocalories per day will be the primary dietary outcome.	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	Children's frequency of physical activity will be assessed using the Physical Activity Recall. This interview measure asks respondents to report the amount of time they spent in moderate and vigorous activities during the previous 7 days.	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	The Pediatric Quality of Life Questionnaire is a 23-item measure of perceptions of how health affects daily life in 4 areas: physical, emotional, social, and school. Scores range from 0 - 100, with higher scores indicating greater quality of life.	Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline
Change in Child Weight in Kilograms	Weight will be measured to the nearest 0.1kg using a digital scale.	Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline
Change in Child Height in Meters	Height will be measured to the nearest 0.1cm using a precision stadiometer.	Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline
Change in Accelerometry	Accelerometers (Actigraph GT3X) will be worn for 1 week by children for each assessment period to assess physical activity objectively.	Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2023
• Primary Completion (Estimated): January 14, 2025
• Study Completion (Estimated): March 14, 2025

Study Registration Dates

• First Submitted: August 10, 2021
• First Submitted That Met QC Criteria: August 26, 2021
• First Posted (Actual): September 2, 2021

Study Record Updates

• Last Update Posted (Actual): June 20, 2024
• Last Update Submitted That Met QC Criteria: June 18, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: IRB-220-317; K23AT011049 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No