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Completed

NCT Number: NCT01374646

Community-based Program to Treat Childhood Obesity

This study will evaluate the effectiveness of a comprehensive community based program on reducing excess weight in children and teens. This study will recruit 150 participants between the ages of 6-12 and 13-17.

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Key information

Conditions

Childhood Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

YMCA of Greater Providence

Providence, Rhode Island, 02903, United States

About this study

This study will evaluate the effectiveness of a comprehensive community based program on reducing excess weight. Overweight and obese study participants will be grouped with peers of similar ages and their parent/guardians. The participants will be divided into 2 groups, child (6-12 yrs. old) and teens (13-17 yrs. old) and will be accompanied by their parent/guardian. 150 participants will be recruited for this study.

This 6-month program (12 in-person group workshop sessions and 12 at-home sessions) takes the best components of current evidence for individual treatment and places them in a comprehensive community based program. These include:

  • Parental involvement
  • Reduction in consumption of sugar sweetened beverages
  • Reduction of screen time
  • Self-monitoring
  • Physical activity
  • Stimulus control

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children and teens between the ages of 6-17
  • BMI percentile ≥85
  • Participation of a parent/guardian

Exclusion criteria

  • Enrollment in another weight loss program or study
  • Diagnosis of type 1 or type 2 diabetes
  • Pre-existing medical conditions (e.g., Prader Willi) that affect weight and appetite
  • Medications (e.g., steroids) that affect weight or appetite
  • Serious or unstable medical or psychological conditions that, in the opinion of the Principal Investigator, would compromise the participant's safety or successful participation in the study

Treatment and study plan

JOIN Intervention

Behavioral

Behavioral group treatment for overweight and obese children and teens, that focuses on decreasing energy dense foods and sedentary behaviors.

Primary outcomes

  1. Change in weight and body mass index (BMI) in children and teens at 6 months

    Time frame: 6 Months

    Assess the effects of a community based program on weight change in children ages 6-12 and teens ages 13-17. Assessments will occur at baseline, 3 and 6 months.

Secondary outcomes

  1. Change in weight and BMI in parent/guardian/care giver at 6 months

    Time frame: 6 months

    Assess the effects of a community based program on weight change in parent/guardian/care givers. Assessments will occur at baseline, 3 and 6 months.

  2. Change in physical activity level in children and teens at 6 months

    Time frame: 6 months

    Assess the effects of a community based program on physical activity level. Accelerometers will be used to access change at baseline, 3 and 6 months.

  3. Changes in intake and sedentary behavior at 6 months

    Time frame: 6 months

    Change in the number of sugar sweetened beverages consumed per day, hours per day on screen time (TV, video games, and computer), and quality of life at 6 months. Assessments will occur at baseline, 3 and 6 months.

  4. Process Outcomes

    Time frame: 6 Months

    Assess process outcomes measures, such as attendance and program satisfaction.

Sponsors and collaborators

Lead sponsor

UnitedHealth Group

Industry

Registry information

Official study title

Effects of a Community-based Program to Treat Childhood and Adolescent Obesity

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 16, 2011
Registry last updated
Jun 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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