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Reducing Maternal Stress to Improve Obesity-related Parenting Practices

Primary Purpose

Obesity, Childhood

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CCC
Enhanced Usual Care
Sponsored by
American University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obesity, Childhood

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • American UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Calma, Conversa, y Cría (CCC)

Enhanced Usual Care

Arm Description

Mindfulness-based parental stress reduction intervention

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

Outcomes

Primary Outcome Measures

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.
Participant Retention
Research staff will take attendance during each intervention session.

Secondary Outcome Measures

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.
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.
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.
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.
Change in height in meters
Height will be measured to the nearest 0.1cm using a precision stadiometer.
Change in weight in kilograms
Weight will be measured to the nearest 0.1kg using a digital scale.

Full Information

First Posted
August 10, 2021
Last Updated
July 20, 2023
Sponsor
American University
Collaborators
National Center for Complementary and Integrative Health (NCCIH), Virginia Commonwealth University, George Washington University, Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT05032430
Brief Title
Reducing Maternal Stress to Improve Obesity-related Parenting Practices
Official Title
Reducing Maternal Stress to Improve Obesity-related Parenting Practices
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 25, 2023 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
American University
Collaborators
National Center for Complementary and Integrative Health (NCCIH), Virginia Commonwealth University, George Washington University, Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Calma, Conversa, y Cría (CCC)
Arm Type
Experimental
Arm Description
Mindfulness-based parental stress reduction intervention
Arm Title
Enhanced Usual Care
Arm Type
Active Comparator
Arm Description
Comparator group designed to influence health and well-being that does not include mindfulness as an active ingredient.
Intervention Type
Behavioral
Intervention Name(s)
CCC
Intervention Description
A mix of mindfulness-based stress reduction, mindful eating, and mindful parenting strategies.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Usual Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Participant Satisfaction with Intervention Assessed by the Client Satisfaction Questionnaire
Description
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.
Time Frame
Immediately after the intervention
Title
Participant Retention
Description
Research staff will take attendance during each intervention session.
Time Frame
At the beginning of each of the 6 weekly intervention sessions
Secondary Outcome Measure Information:
Title
Change in the Five Facet Mindfulness Questionnaire
Description
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.
Time Frame
Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline
Title
Change in the Perceived Stress Scale
Description
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.
Time Frame
Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline
Title
Change in the Child Feeding Questionnaire
Description
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.
Time Frame
Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline
Title
Change in the Frequency of Family Eating and Exercise Behaviors Questionnaire
Description
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.
Time Frame
Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline
Title
Change in height in meters
Description
Height will be measured to the nearest 0.1cm using a precision stadiometer.
Time Frame
Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline
Title
Change in weight in kilograms
Description
Weight will be measured to the nearest 0.1kg using a digital scale.
Time Frame
Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline
Other Pre-specified Outcome Measures:
Title
Change in Child Daily Kilocalories via 3-Day Food Record
Description
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.
Time Frame
Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline
Title
Change in Child Frequency of Physical Activity as Assessed by the Physical Activity Recall Screen
Description
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.
Time Frame
Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline
Title
Change in Child Quality of Life as Assessed by the Pediatric Health-Related Quality of Life Questionnaire
Description
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.
Time Frame
Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline
Title
Change in Child Weight in Kilograms
Description
Weight will be measured to the nearest 0.1kg using a digital scale.
Time Frame
Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline
Title
Change in Child Height in Meters
Description
Height will be measured to the nearest 0.1cm using a precision stadiometer.
Time Frame
Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline
Title
Change in Accelerometry
Description
Accelerometers (Actigraph GT3X) will be worn for 1 week by children for each assessment period to assess physical activity objectively.
Time Frame
Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Cotter, PhD
Phone
2028853703
Email
cotter@american.edu
Facility Information:
Facility Name
American University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Cotter

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Reducing Maternal Stress to Improve Obesity-related Parenting Practices

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