Clinical trial NCT05032430: Reducing Maternal Stress to Improve Obesity-related Parenting Practices
Official title: Reducing Maternal Stress to Improve Obesity-related Parenting Practices
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity, Childhood
Lead sponsor: American University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: Virginia Commonwealth University
name: George Washington University
name: Johns Hopkins University
First posted: 2021-09-02
Enrollment: 115
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Participant Satisfaction with Intervention Assessed by the Client Satisfaction Questionnaire
timeFrame: Immediately after the intervention
measure: Participant Retention
timeFrame: At the beginning of each of the 6 weekly intervention sessions
Secondary outcomes:
measure: Change in the Five Facet Mindfulness Questionnaire
timeFrame: Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline
measure: Change in the Perceived Stress Scale
timeFrame: Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline
measure: Change in the Child Feeding Questionnaire
timeFrame: Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline
measure: Change in the Frequency of Family Eating and Exercise Behaviors Questionnaire
timeFrame: Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline
measure: Change in height in meters
timeFrame: Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline
measure: Change in weight in kilograms
timeFrame: Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline
Other outcomes:
measure: Change in Child Daily Kilocalories via 3-Day Food Record
timeFrame: Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline
measure: Change in Child Frequency of Physical Activity as Assessed by the Physical Activity Recall Screen
timeFrame: Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline
measure: Change in Child Quality of Life as Assessed by the Pediatric Health-Related Quality of Life Questionnaire
timeFrame: Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline
measure: Change in Child Weight in Kilograms
timeFrame: Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline
measure: Change in Child Height in Meters
timeFrame: Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline
measure: Change in Accelerometry
timeFrame: Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline
Locations:
city: Washington
country: United States
facility: American University
state: District of Columbia
Study officials:
References: