Mindful Parenting Program for Childhood Obesity

Not currently recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a mindful parenting program can help Latina mothers reduce stress and improve their children's health, with a focus on obesity. Researchers are comparing a program called Calma, Conversa, y Cría (CCC) with another type of care, known as ATIENDE, to determine which is more effective. The goal is to discover if teaching stress-reducing parenting techniques can foster healthier home environments. Latina mothers of children aged 3 to 11 who primarily live with them may be suitable for this study. By participating, they will assist researchers in evaluating the program's effectiveness and potential benefits. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could benefit many families.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this mindful parenting program is safe?

Research shows that the Calma, Conversa, y Cría (CCC) program aims to help Latina mothers reduce stress through mindfulness techniques. Although specific safety data for the CCC program is not yet available, similar mindfulness activities have proven safe in other studies. Participants often report feeling more relaxed and less stressed, with no major side effects. Mindfulness focuses on mental exercises, which are generally safe. For any concerns, participants should consult the trial team, who can provide information specific to individual situations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mindful Parenting Program for Childhood Obesity because it introduces a mindfulness-based approach to tackling obesity, something not typically emphasized in standard treatments like dietary changes and physical activity. The experimental treatment, Calma, Conversa, y Cría (CCC), focuses on reducing parental stress through mindfulness, which can indirectly influence healthier lifestyle choices and emotional well-being in children. This approach is unique as it targets the familial environment and stress management, rather than just focusing on the child's direct behaviors, offering a holistic strategy that might enhance overall family health and support sustainable weight management.

What evidence suggests that this trial's treatments could be effective for childhood obesity?

Research shows that mindfulness activities, such as Calma, Conversa, y Cría (CCC), one of the interventions in this trial, can reduce parental stress. Lower stress levels in parents contribute to a healthier home environment, which can help prevent childhood obesity. Studies have found that when parents practice mindfulness, their parenting skills often improve. This improvement can create a more supportive home, potentially helping children maintain a healthy weight. While researchers are still studying whether CCC directly reduces obesity, the benefits of mindfulness in parenting appear promising. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10336400/

A pilot mindful parenting intervention with Latina women - PMC We describe a study design that will examine the acceptability and feasibility of Calma, Conversa, y Cría (CCC) a 6-week mindful parenting intervention ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37448911/

A pilot mindful parenting intervention with Latina women Methods: Herein we describe a study design that will examine the acceptability and feasibility of Calma, Conversa, y Cría (CCC) a 6-week mindful ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714420303219

Design and rationale for ADAPT+ ADAPT+ is a multi-family intervention for rural Latino youth with obesity, adding mindfulness to reduce parent stress, combining family-based and mindfulness ...

4. hsrc.himmelfarb.gwu.edu hsrc.himmelfarb.gwu.edu/gwhpubs/3308/

"Rationale, formative research, and protocol for Calma ... We describe a study design that will examine the acceptability and feasibility of Calma, Conversa, y Cría (CCC) a 6-week mindful parenting intervention ...

5. researchgate.net researchgate.net/publication/353090919_O19_A_Mindful_Parenting_Intervention_for_Obesity_Prevention_in_Early_Childhood

O19 A Mindful Parenting Intervention for Obesity ... Methods: Herein we describe a study design that will examine the acceptability and feasibility of Calma, Conversa, y Cría (CCC) a 6-week mindful ...

6. withpower.com withpower.com/trial/phase-obesity-2022-57adc

Mindful Parenting Program for Childhood Obesity The investigators will conduct a randomized clinical trial comparing the Calma, Conversa, y Cría (CCC) intervention to an active control condition in 50 Latina ...

7. researchgate.net researchgate.net/publication/232610868_Influence_of_Stress_in_Parents_on_Child_Obesity_and_Related_Behaviors

Influence of Stress in Parents on Child Obesity and Related ... Rationale, formative research, and protocol for Calma, Conversa, y Cría: A pilot mindful parenting intervention with Latina women. Article.