Reducing Maternal Stress to Improve Obesity-related Parenting Practices

Obesity, Childhood Clinical Trial

Official title:

Reducing Maternal Stress to Improve Obesity-related Parenting Practices

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05032430
• Other study ID #: IRB-220-317
• Secondary ID: K23AT011049
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 25, 2023
• Est. completion date: March 14, 2025

Study information

• Verified date: June 2024
• Source: American University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 115
• Est. completion date: March 14, 2025
• Est. primary completion date: January 14, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Obesity, Childhood
• Pediatric Obesity

Intervention

Behavioral:
• CCC
A mix of mindfulness-based stress reduction, mindful eating, and mindful parenting strategies.
• 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.

Locations

Country	Name	City	State
United States	American University	Washington	District of Columbia

Sponsors (5)

Lead Sponsor	Collaborator
American University	George Washington University, Johns Hopkins University, National Center for Complementary and Integrative Health (NCCIH), Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	Participant Retention	Research staff will take attendance during each intervention session.	At the beginning of each of the 6 weekly intervention sessions
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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