Diet and Physical Activity for Childhood Obesity

(MOYD Trial)

Overseen By Tim Thomas

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Alaska Native Tribal Health Consortium

Disqualifiers: Lack of parental consent, others

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

Compensation: Varies

Number of Visits: Unknown

450 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

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

What data supports the effectiveness of the treatment Wedge 1 for childhood obesity?

Research shows that increasing physical activity and reducing sedentary behavior can help treat childhood obesity, although the evidence is not very strong. Additionally, dietary interventions often lead to significant short-term weight loss in children, but more high-quality studies are needed to confirm long-term effectiveness. ^{1 2 3 4 5}

Is the diet and physical activity treatment for childhood obesity safe?

The safety of diet and physical activity treatments for childhood obesity is not well-documented in the existing literature. While these interventions are effective for weight loss, there is limited information on potential adverse effects, and more research is needed to assess their long-term safety. ^{4 6 7 8 9}

How does the treatment Wedge 1 differ from other treatments for childhood obesity?

Wedge 1 is unique because it combines diet and physical activity components with a home element, which has shown the greatest effectiveness in school-based interventions for preventing childhood obesity. This approach is promising as it integrates multiple lifestyle changes, unlike treatments that focus solely on diet or exercise. ^{3 9 10 11 12}

What is the purpose of this trial?

The preschool age is a crucial period of growth and an optimal time to begin to establish healthy eating and physical activity habits leading to better food and activity choices into adulthood, thereby minimizing risk for obesity-related diseases and decreasing the cardiometabolic disparities in this Indigenous population. More Outside Your Door is a multi-level, randomized, stepped-wedge intervention trial designed to reduce the disparity of childhood obesity in Yup'ik Alaska Native children by increasing the proportion of nutrient-dense traditional and traditional-like foods offered and increasing physical activity, particularly outdoor activities related to traditional Yup'ik subsistence and lifestyle practices. This 5-year intervention trial targeting 3-5 year olds is conducted in partnership with Rural Action Community Action Program Head Start programs in 12 rural Alaskan communities, where each site is assigned annually to a wedge group to receive either a community-altered culturally-tailored 8-month traditional foods and activities curriculum intervention or the standard regional Head Start program intervention.

Eligibility Criteria

This trial is for Yup'ik Alaska Native preschoolers aged 3-5 years old. It aims to establish healthy eating and physical activity habits early on, focusing on nutrient-dense traditional foods and outdoor activities related to their culture. The study excludes those who do not meet the specific age range or cultural background.

Inclusion Criteria

Present at school for health screenings

Parent who identifies as Alaska Native (AN)

Parental consent

Exclusion Criteria

Lack of parental consent

Does not have a parent who is AN

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a community-altered culturally-tailored 8-month traditional foods and activities curriculum intervention

8 months

Regular visits as part of the Head Start program

Control

Participants in Wedges 2 & 3 act as controls while Wedge 1 undergoes intervention

8 months

Follow-up

Participants are monitored for changes in diet, physical activity, BMI, and other risk factors for obesity-related chronic disease

3 years

Treatment Details

Interventions

• Wedge 1

Trial Overview The 'More Outside Your Door' intervention compares a culturally-tailored curriculum promoting traditional foods and physical activities with the standard regional Head Start program. This stepped-wedge trial randomly assigns communities annually to receive either the specialized intervention or continue with regular programming over five years.

Participant Groups

Group I: Wedge 1 Experimental Treatment 1 Intervention

Four villages of 12 will be randomized into Wedge 1. Four of the remaining 8 villages will be randomized to Wedge 2. The remaining 4 villages will be Wedge 3.

Group II: Wedge 2 Active Control 1 Intervention

While Wedge 1 is undergoing intervention, Wedges 2 \& 3 will act as controls.

Group III: Wedge 3 Active Control 1 Intervention

While Wedge 1 is undergoing intervention, Wedges 2 \& 3 will act as controls.

Who Is Running the Clinical Trial?

Alaska Native Tribal Health Consortium

Lead Sponsor

Trials

20

Recruited

9,600+

University of Alaska Anchorage

Collaborator

Trials

8

Recruited

2,300+

Washington State University

Collaborator

Trials

114

Recruited

58,800+

Findings from Research

A five-year study involving 220 children aged 5 to 13 showed significant reductions in obesity, with the most substantial improvements seen in the youngest age group (4-6 years).

After treatment, 48% of the children were no longer classified as obese, and 72% achieved a decrease of at least 0.5 BMI standard deviation score, indicating that early intervention is crucial for effective obesity treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five-year outpatient programme that provided children with continuous behavioural obesity treatment enjoyed high success rate. Danielsson, P., Bohlin, A., Bendito, A., et al.[2017]

After 12 months post-intervention, there was no significant difference in BMI between children who received individual family-based treatment and those in group-based treatment, indicating both methods were similarly effective in the short term.

However, the group intervention showed a significant improvement in cardiometabolic risk factors, specifically C peptide levels, suggesting potential benefits beyond just weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

No additional long-term effect of group vs individual family intervention in the treatment of childhood obesity-A randomised trial. Kokkvoll, AS., Grimsgaard, S., Flaegstad, T., et al.[2021]

The review identified a total of four new randomized controlled trials and two systematic reviews, indicating a significant increase in research on childhood obesity prevention and treatment since previous reviews, but high-quality evidence remains limited.

While there is some promise in targeting reductions in sedentary behavior and increasing physical activity for treating pediatric obesity, the effectiveness of these interventions is still uncertain, and more research is needed, especially outside the USA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity interventions in the prevention and treatment of paediatric obesity: systematic review and critical appraisal. Reilly, JJ., McDowell, ZC.[2022]

A systematic review of 116 articles found that dietary interventions generally lead to significant short-term weight loss in children and adolescents who are overweight or obese, but many studies lacked rigorous design and follow-up.

There is a critical need for high-quality research to determine the best dietary strategies for managing pediatric obesity, with a focus on long-term sustainability and detailed reporting of dietary interventions and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of interventions in the management of overweight and obese children which include a dietary component. Collins, CE., Warren, JM., Neve, M., et al.[2011]

Surgical options for treating adolescent obesity have been shown to be both safe and effective, making them a viable treatment choice for severe cases.

To improve treatment outcomes, individualized protocols of varying intensity should be developed based on each patient's severity of obesity and risk factors, ideally through multidisciplinary clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric obesity. Holterman, MJ., Le Holterman, AX., Browne, AF.[2012]

This scoping review identified 18 outcome domains from 161 randomized controlled trials focused on preventing childhood obesity in the first 5 years of life, highlighting the need for standardized measures in this area.

The most commonly reported outcome was anthropometry, found in 92% of studies, indicating a strong focus on physical measurements like body mass index, which was reported in over half of the studies, showcasing the variability in how childhood obesity prevention is assessed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A scoping review of outcomes commonly reported in obesity prevention interventions aiming to improve obesity-related health behaviors in children to age 5 years. Brown, V., Moodie, M., Sultana, M., et al.[2022]

A structured weight management program for obese children and adolescents led to significant reductions in body weight, BMI, and BMI percentiles after just 3 months, with continued improvements observed at 6 and 12 months for those who maintained participation.

Children who participated in the program showed improved fitness levels, while control group participants experienced weight gain and increased BMI, highlighting the program's effectiveness in promoting healthier outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A combined nutritional-behavioral-physical activity intervention for the treatment of childhood obesity--a 7-year summary. Nemet, D., Levi, L., Pantanowitz, M., et al.[2014]

Very low-energy diet (VLED) programs are effective for weight loss in children and adolescents with obesity, showing a mean weight loss of 10.1 kg after interventions lasting 3 to 20 weeks, based on a meta-analysis of 20 studies.

While VLED programs significantly improve weight-related outcomes, the existing literature lacks sufficient data on safety and adverse events, highlighting the need for future studies to monitor these aspects and provide long-term follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of very low-energy diet programs for weight loss: A systematic review with meta-analysis of intervention studies in children and adolescents with obesity. Andela, S., Burrows, TL., Baur, LA., et al.[2020]

Combining dietary changes with behavioral management techniques, like setting short-term goals, is effective in treating obesity in children.

Increasing physical activity alongside dietary interventions is crucial for achieving weight loss in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective dietary therapies for pediatric obesity treatment. Fitch, A., Bock, J.[2021]

School-based interventions that combine diet and physical activity are the most effective strategies for preventing childhood obesity, based on a systematic review of 41 studies.

There is a need for more rigorous research in non-school settings, as evidence for preschool, community, and home-based interventions is limited and varied.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to prevent global childhood overweight and obesity: a systematic review. Bleich, SN., Vercammen, KA., Zatz, LY., 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]

Lifestyle exercise programs that include behavior modification, diet, and parental involvement have shown significant long-term results in reducing pediatric obesity, highlighting the importance of comprehensive approaches.

Current studies indicate that interventions aimed at reducing sedentary behaviors, such as limiting screen time, can lead to meaningful decreases in body mass index among children, suggesting that both weight loss and weight gain prevention strategies are essential for tackling obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions for weight loss and weight gain prevention among youth: current issues. Fulton, JE., McGuire, MT., Caspersen, CJ., et al.[2018]

References

1. Norway pubmed.ncbi.nlm.nih.gov

Five-year outpatient programme that provided children with continuous behavioural obesity treatment enjoyed high success rate. [2017]

2. Norway pubmed.ncbi.nlm.nih.gov

No additional long-term effect of group vs individual family intervention in the treatment of childhood obesity-A randomised trial. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Physical activity interventions in the prevention and treatment of paediatric obesity: systematic review and critical appraisal. [2022]

4. Australia pubmed.ncbi.nlm.nih.gov

Systematic review of interventions in the management of overweight and obese children which include a dietary component. [2011]

5. United States pubmed.ncbi.nlm.nih.gov

Pediatric obesity. [2012]

6. England pubmed.ncbi.nlm.nih.gov

A scoping review of outcomes commonly reported in obesity prevention interventions aiming to improve obesity-related health behaviors in children to age 5 years. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

A combined nutritional-behavioral-physical activity intervention for the treatment of childhood obesity--a 7-year summary. [2014]

8. England pubmed.ncbi.nlm.nih.gov

Efficacy of very low-energy diet programs for weight loss: A systematic review with meta-analysis of intervention studies in children and adolescents with obesity. [2020]

9. Germany pubmed.ncbi.nlm.nih.gov

Effective dietary therapies for pediatric obesity treatment. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Interventions to prevent global childhood overweight and obesity: a systematic review. [2022]

11. Norway pubmed.ncbi.nlm.nih.gov

Physical activity-key issues in treatment of childhood obesity. [2015]

12. New Zealand pubmed.ncbi.nlm.nih.gov

Interventions for weight loss and weight gain prevention among youth: current issues. [2018]