Mindful Parenting Program for Childhood Obesity

Overseen By Elizabeth Cotter, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: American University

Disqualifiers: Pregnancy, Substance dependence, Untreated psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

115 Participants Needed

Trial Summary

What is the purpose of this trial?

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

This trial is for Latina mothers over 18 years old with a child aged 3-11 who lives primarily with them. It aims to help reduce maternal stress and improve parenting practices related to childhood obesity. Women must understand Spanish or English, not be pregnant or planning pregnancy soon, and cannot have untreated severe mental health issues.

Inclusion Criteria

Identify as Hispanic or Latina

I identify as female.

I am over 18 years old.

Exclusion Criteria

My child has a genetic condition linked to obesity.

Actively dependent on a substance

Have untreated psychosis, PTSD, or social anxiety that would impair their ability to function in a group setting

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants undergo the Calma, Conversa, y Cría (CCC) mindfulness-based parental stress reduction intervention or an active control condition

6 weeks

6 weekly sessions

Follow-up

Participants are monitored for changes in stress, parenting practices, and child health outcomes

10 months

3 assessment points: baseline, immediately after intervention, and 10 months from baseline

Treatment Details

Interventions

• ATIENDE
• Enhanced Usual Care
• Modified Health Enhancement Program

Trial Overview The study tests a program called Calma, Conversa, y Cría (CCC), which combines mindfulness-based stress reduction with mindful parenting techniques. The goal is to see if this culturally-tailored intervention can lower stress in Latina mothers and promote healthier environments for their children.

Participant Groups

Group I: Calma, Conversa, y Cría (CCC) Experimental Treatment 1 Intervention

Mindfulness-based parental stress reduction intervention

Group II: Enhanced Usual Care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

American University

Lead Sponsor

Trials

22

Recruited

5,600+

Virginia Commonwealth University

Collaborator

Trials

732

Recruited

22,900,000+

George Washington University

Collaborator

Trials

263

Recruited

476,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+