Comparing Outcomes Among Children With Obesity in a Community Healthy Lifestyle Program
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-14
SponsorUniversity of Texas Southwestern Medical Center
About this trial
This study aims to evaluate the outcomes of an existing clinical program that teaches families of children with overweight and obesity healthy lifestyle. The design will be unblinded, randomized, waitlist control.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
BMI by report of ≥ 85th percentile
The child must be able to participate in physical activity comparable to an elementary school PE class and must be able to function cognitively at or above the level of a 6 year old
Disqualifiers
BMI by report of below the 85th percentile
Inability to participate in physical activity comparable to an elementary school PE class and must be able to function cognitively at or above the level of a 6 year old
Trial design
Design model
Parallel
Treatments tested in this trial
Get Up & Go Healthy Lifestyle Program
BehavioralThis study evaluates an established pediatric healthy weight program, Get Up \& Go. There are 10 weekly sessions for child (ages 6-14 years) and parent. Each 90-minutes session includes an interactive lesson on some aspect of healthy living, a fun game or physical activity that involves both children and parents, a healthy snack, and a time for families to set a lifestyle change goal for the week and to review achievement of goals set the prior week. Virtual components bring the total content exposure to over 26 hours provided. Curriculum: Principles of healthy living Healthy eating basics Division of responsibility Nutrition 101 Bullying prevention Meal time Advertising and dining Grocery store tour Graduation
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Program Intervention ArmExperimental treatment 1 intervention
Group B: Waitlist Control ArmNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
BMI status
Change in child BMI status, using %BMIp95 as primary outcome and BMI z score. Both are calculations made from weight, height, sex, and age.
Time frame
From enrollment to the end of intervention period at 3 monthsSecondary outcomes
1
Family Nutrition and Physical Activity (FNPA)
Family Nutrition and Physical Activity (FNPA), a validated 30-item questionnaire from the Academy of Nutrition and Dietetics, will be completed by parent. The questions ask about home practices related to nutrition, physical activity, sleep and other health routines. The instrument has been broadly utilized since it was validated in 2009 . The FNPA has been used to assess modifiable healthy lifestyle behaviors, with an emphasis on behaviors that contribute to obesity . Each questions are rated on a scale of 1 to 4. Higher aggregate scores point to healthier decision making. Lower scores point to less healthy behaviors.
Time frame
From enrollment to the end of intervention period at 3 months2
BAQ: Behavior Assessment Questionnaire
Behavior Assessment Questionnaire (BAQ) is a self reported tool measuring a child's lifestyle behaviors. It examines frequency of habits such as eating, activity, emotional health, sleep, and environment. Each of the 10 questions has 4 response options describing frequency or timing of stem question. The responses are assigned scores of 0-4, and total scores are converted to a 0-100 scale. Higher aggregate scores point to healthier habits, and lower scores point to less healthy behaviors.
Time frame
From enrollment to the end of intervention period at 3 months3
Endurance (PACER)
Progressive Aerobic Cardiovascular Endurance Run (PACER): participants run a 15 m distance at a progressively faster pace, and the score is the number of laps successfully completed
Time frame
From enrollment to the end of intervention period at 3 months4
Parental Weight Measures
Optional: Parent BMI, using absolute BMI (kg/m2)
Time frame
From enrollment to the end of intervention period at 3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Texas Southwestern Medical Center
Lead sponsor
Children's Medical Center Dallas
Collaborator
Source ClinicalTrials.gov