Mentoring for Physical Activity in Overweight Children

Overseen By Sandra Solove, MA

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Not in 7th grade, others

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

Compensation: Varies

Number of Visits: 10

432 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to boost physical activity among children who are overweight or obese, focusing on rural Appalachian communities. It combines peer mentoring with family support to encourage kids to get moving without special exercise equipment. The study includes two groups: one receives mentoring sessions and family programs (Mentoring to be Active plus Family), while the other follows self-guided health modules and a rewards-based plan. Children in 7th grade, with a body mass index (BMI) over the 85th percentile, and internet access at home might be a good fit for this study. As an unphased trial, this study offers families a unique opportunity to participate in innovative health programs designed to improve children's well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the Mentoring to be Active plus Family (MPBA+F) program helps children become more active. Studies have found no serious side effects, indicating safety for participants. The program emphasizes mentoring and family support to encourage activity in children, without relying on medications or physical treatments. This approach makes it a safe choice for children. Participants generally found the program easy to follow and helpful in building exercise habits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Mentoring to be Active plus Family" (MPBA+F) approach because it combines virtual peer mentoring with guided family involvement, setting it apart from traditional exercise programs. Unlike standard treatments that often rely solely on physical activity guidelines or professional-led sessions, MPBA+F empowers children through peer support and personalized goal-setting in a virtual setting, making it accessible and engaging. Additionally, the program includes a unique parent-directed component, ensuring that families are actively involved in supporting their child's fitness journey at home. By integrating social support and family engagement, researchers hope to inspire sustainable lifestyle changes in overweight children.

What evidence suggests that this trial's treatments could be effective for increasing physical activity in overweight children?

Research has shown that the Mentoring to be Active plus Family (MPBA+F) program, a treatment arm in this trial, can increase physical activity in children. This program combines peer mentoring with family support to keep kids active without special equipment. Early results suggest it not only boosts activity levels but also improves body composition, leading to a healthier balance of muscle and fat. Designed specifically for children in rural Appalachian areas, the program addresses community needs and focuses on activities that can be done at home. Overall, the MPBA+F program helps children build long-term habits that may reduce the risk of obesity and diabetes. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for 7th graders in rural Appalachia with a body mass index at or above the 85th percentile, who aren't under care for obesity or type 1 diabetes. Participants need internet, a computer or tablet at home, and must not plan to move before the study ends. They should also read English at a 5th grade level and have a home address and phone number.

Inclusion Criteria

High school peer mentors recommended by a teacher, school advisor, or counselor

My child's BMI is in the 85th percentile or higher for their age and gender.

My child is starting 7th grade.

Exclusion Criteria

My child is not in the 7th grade at the start of this study.

My child is not overweight or obese.

High school peer mentors who cannot speak and read English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Peer Mentoring

Ten peer-mentoring sessions delivered virtually with a Project Leader, peer mentors, and mentees. Each session includes a content lesson, guided practice, social support, feedback, and personal goal-setting.

10 weeks

10 virtual sessions

Family Reinforcement

A guided, parent-directed 6-module program to support the child's home-based physical activity.

6 months

Follow-up

Participants are monitored for changes in body composition and physical activity behaviors.

9 months

What Are the Treatments Tested in This Trial?

Interventions

• Mentoring to be Active plus Family

Trial Overview The trial tests 'Mentoring to be Active plus Family' (MPBA+F), which combines peer mentoring with family support to encourage physical activity without exercise equipment. It aims to improve children's health by leveraging social networks and culturally tailored strategies.

How Is the Trial Designed?

Group I: Mentoring to be Active plus Family (MPBA+F) Experimental Treatment 1 Intervention

For the first phase, ten peer-mentoring sessions (1 day/week for 45 minutes each week) delivered virtually with a Project Leader, five peer mentors, and 8-10 mentees with 1:2 mentor/mentee ratios. Each session consists of a 10-15 minute content lesson followed by 20-30 minutes of guided practice, social support, feedback, and personal goal-setting for the following week in small peer mentor/mentee "break-out" rooms. Mentees track activities and efforts towards meeting personal goals. Parents return their child's weekly completed 'Tracker" forms either electronically via the secure, password-protected project website or (if they prefer) by regular pre-paid mail service. The reinforcement component of MPBA+F is a guided, parent-directed 6-module (0nce a month for 6 months) program for parents/guardians to further support the child's home-based PA. Child participants assigned to MPBA will be provided the modules.

Group II: Tracking Health and Fitness Active Control 1 Intervention

Half of child participants will receive "Tracking your Health and Fitness", a comparison program of 10 weekly, self-guided modules from Ohio State University (OSU) Extension mailed to their home. Child participants assigned to the "Tracking Health and Fitness" program (comparison group) may voluntarily participate in a 6-month rewards-based self-regulation program to encourage sustainability of weekly PA.

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Published Research Related to This Trial

Physical activity interventions for overweight and obese children and adolescents often face challenges like modest success rates and high dropout, highlighting the need for well-designed programs to improve adherence and health benefits.

The paper outlines ten key lessons for effective physical activity interventions, including the importance of a fun and varied activity selection, parental involvement, and a multidisciplinary approach to address individual needs and barriers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Top 10 practical lessons learned from physical activity interventions in overweight and obese children and adolescents. Alberga, AS., Medd, ER., Adamo, KB., et al.[2018]

In a randomized clinical trial involving 188 parents of young children, the use of parent mentors did not lead to significant changes in obesity measures (BMI) overall after 6 months, indicating limited efficacy of this intervention.

However, among those who actively participated, higher engagement with the We Can! program was associated with a smaller increase in adiposity, suggesting that participation level may influence outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Growing Healthy Together: A Randomized Clinical Trial Using Parent Mentors for Early Childhood Obesity in Low-Income, Latino Families. Foster, BA., Weinstein, K., Padilla, T., et al.[2023]

Children from racial minority families reported higher levels of sedentary behavior and family discouragement of exercise, indicating a need for targeted interventions to promote physical activity in these groups.

Family participation in exercise was significantly associated with increased physical activity levels in children, suggesting that engaging families in physical activities together could enhance the effectiveness of medical weight management programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parents' Reports of Children's Physical and Sedentary Behavior Engagement among Parents in Weight Management. Van Fossen, C., Kiser, H., Lambert Brown, C., et al.[2023]

The study enrolled 60 parent-child pairs from a Hispanic community to evaluate the effectiveness of parent mentors in addressing early childhood obesity, with a focus on improving BMI and dietary habits.

The intervention showed high retention rates (90% over three months), indicating feasibility and acceptability among participants, which is crucial for community-based health initiatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized clinical trial of the effects of parent mentors on early childhood obesity: Study design and baseline data. Foster, BA., Aquino, C., Gil, M., et al.[2021]

Engaging youth mentors in a childhood obesity prevention program led to significant improvements in their dietary habits, including a decrease in caloric intake and waist circumference, indicating positive changes in their health behaviors.

The mentors reported enhanced nutrition, physical activity, and mental health behaviors, along with a strengthened commitment to higher education and career goals, suggesting that mentoring can benefit both the mentors and the children they serve.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Youth Mentor Dietary Outcomes and Waist Circumference Improvement: Camp NERF Study Findings. Hopkins, LC., Webster, A., Kennel, JA., et al.[2022]

Increasing physical activity is crucial in treating childhood obesity, as it not only helps with weight management but also improves metabolic health and psychological well-being.

The paper provides practical recommendations for healthcare providers to encourage obese children and their families to engage in daily activities, participate in sports, reduce sedentary behaviors, and involve their social circles in supporting healthier lifestyles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity-key issues in treatment of childhood obesity. Nowicka, P., Flodmark, CE.[2015]

Parent mentors showed strong commitment and faced challenges in engaging other parents, but their nonjudgmental approach was appreciated, indicating a positive dynamic in mentoring for childhood obesity.

Parent mentees rated their mentors highly, similar to professional community health workers, suggesting that this peer-led intervention could be an effective and scalable strategy for promoting behavioral change in childhood obesity, particularly in Hispanic communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors Associated with Successful Mentoring of Parents Addressing Childhood Obesity: A Mixed Methods Approach. Villanueva, GA., Foster, BA.[2020]

In a 12-week family-based program called Building Healthy Families, 22 obese children lost an average of 2.3 kg, while their parents lost an average of 6.4 kg, indicating the program's effectiveness in promoting weight loss for both children and parents.

The study found that reducing the intake of high-fat, high-calorie foods was a strong predictor of weight loss in children, highlighting the importance of dietary changes in successful obesity treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of a Family Based Pediatric Obesity Program - Preliminary Results. Ruebel, ML., Heelan, KA., Bartee, T., et al.[2019]

A survey of pediatric weight management programs from 25 children's hospitals revealed that while all programs included physical activity assessment and counseling, there was significant variability in how these practices were implemented.

The FOCUS on a Fitter Future group recommends essential components for effective pediatric weight management programs, including exercise testing, body composition assessment, and both individual and group exercise counseling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity in Clinical Pediatric Weight Management Programs: Current Practices and Recommendations. Kist, C., Gier, A., Tucker, J., et al.[2017]

Citations

1. bmjpublichealth.bmj.com bmjpublichealth.bmj.com/content/2/2/e000798

Randomised trial of Mentored 'Planning to be Active ... This clinical trial tests the effects of the Mentored Planning to be Active+Family intervention on physical activity (PA) and body composition ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05758441

Mentoring to be Active for Rural Appalachia Children Over the course of two years, this study will test the effects of the Mentored Planning to be Active + Family intervention on physical activity outcomes (MVPA, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7185163/

Efficacy of “Mentoring to Be Active” on Weight Loss, Body ... In a sample of 333 ninth-grade rural Appalachian students, Smith and associates found obesity rates were 16.5% and 13.2% of youth were extremely obese.

4. withpower.com withpower.com/trial/phase-physical-activities-3-2023-13f48

Mentoring for Physical Activity in Overweight Children The innovative MPBA+F begins with peer-to-peer mentoring followed by structured parental/family support for long-term reinforcement of PA behaviors.

5. researchgate.net researchgate.net/publication/385498568_Randomised_trial_of_Mentored_'Planning_to_be_ActiveFamily'_MPBAF_for_Appalachian_youth_at_risk_for_diabetes_virtual_delivery_protocol

(PDF) Randomised trial of Mentored 'Planning to be Active ... Introduction Obesity (OB) in children remains a national epidemic. This trial targets children suffering from overweight (OW) and OB living ...