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Completed

NCT Number: NCT02185248

Wellness Action Plan Trial Addressing Childhood Obesity

The objective of this study was to determine the effectiveness of a novel Wellness Action Plan aimed at 1) improving parent recall of diet and activity plans 2) increasing follow-through with plans and 3) aiding parents in identifying their child's weight category.

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Key information

Conditions

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

Age range

30 month–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Downtown Health Center

Milwaukee, Wisconsin, 53233, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Children between the ages of 2.5 and 14 years, regardless of baseline BMI
  • Presented for a well child visit at a pediatric clinic serving primarily Medicaid-insured children in Milwaukee, Wisconsin

Exclusion criteria

  • Patients in foster care
  • Parents and patients who were non-English speaking
  • Patients who were being seen by a specialist for weight management.

Treatment and study plan

Wellness Action Plan

Behavioral

The plan included a color-coded BMI chart to help parents understand their child's weight category as well as a brief action planning worksheet to help families create personalized plans around healthy diet and activity changes.

Primary outcomes

  1. Diet plan recall directly after visit

    Time frame: On day of primary visit

    Parents are given a questionnaire which asks whether they made a diet plan with their physician for their child during the visit and whether they will attempt to follow-through with the plan made.

  2. Activity plan recall directly after visit

    Time frame: On day of primary visit, directly after seeing physician

    Parents are given a questionnaire which asks whether they made an activity plan with their physician for their child during the visit and whether they will attempt to follow-through with the plan made.

Secondary outcomes

  1. Diet plan recall/follow-through 1 month post visit

    Time frame: 4 weeks after primary visit

    Parents are contacted 4 weeks after their primary visit and given a phone questionnaire which asks whether they made a diet plan with their physician for their child during the last visit and whether they can recall the plan. If parents can recall the plan, they are then asked if they followed-through with the plan (yes, no) and how successful they were with the changes (1-10 scale).

  2. Diet plan recall/follow-through 3 months post visit

    Time frame: 12 weeks after primary visit

    Parents are contacted 12 weeks after their primary visit and given a phone questionnaire which asks whether they made a diet plan with their physician for their child during the last visit and whether they can recall the plan. If parents can recall the plan, they are then asked if they followed-through with the plan (yes, no) and how successful they were with the changes (1-10 scale).

  3. Activity plan recall/follow-through 1 month post visit

    Time frame: 4 weeks after primary visit

    Parents are contacted 4 weeks after their primary visit and given a phone questionnaire which asks whether they made an activity plan with their physician for their child during the last visit and whether they can recall the plan. If parents can recall the plan, they are then asked if they followed-through with the plan (yes, no) and how successful they were with the changes (1-10 scale).

  4. Activity plan recall/follow-through 3 months post visit

    Time frame: 12 weeks after primary visit

    Parents are contacted 12 weeks after their primary visit and given a phone questionnaire which asks whether they made an activity plan with their physician for their child during the last visit and whether they can recall the plan. If parents can recall the plan, they are then asked if they followed-through with the plan (yes, no) and how successful they were with the changes (1-10 scale).

  5. BMI category identification directly after the visit

    Time frame: On day of primary visit

    Parents are given a questionnaire which asks whether their physician told them their child's weight category and asks whether they can identify that category.

  6. BMI category identification 1 month post visit

    Time frame: 4 weeks after primary visit

    Parents are contacted 4 weeks after their primary visit and given a phone questionnaire which asks whether their physician told them their child's weight category and asks whether they can identify that category.

  7. BMI category identification 3 months post visit

    Time frame: 12 weeks after primary visit

    Parents are contacted 12 weeks after their primary visit and given a phone questionnaire which asks whether their physician told them their child's weight category and asks whether they can identify that category.

Sponsors and collaborators

Lead sponsor

Roohi Kharofa, MD, MPH

Other

Registry information

Official study title

Randomized Controlled Trial of a Wellness Action Plan to Address the Childhood Obesity Epidemic

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jul 9, 2014
Registry last updated
Mar 24, 2015

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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