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Clinical Trials/NCT02684214
NCT02684214
Completed
Not Applicable

Implementing Prevention Plus for Childhood Overweight and Obesity in Food Secure and Insecure Families

The University of Tennessee, Knoxville1 site in 1 country73 target enrollmentApril 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
The University of Tennessee, Knoxville
Enrollment
73
Locations
1
Primary Endpoint
Target Population Denominator
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The ability of Prevention Plus to improve weight status when delivered by primary care providers is unknown, and the influence of household food security status as a moderator in the treatment of childhood obesity has never been examined. Thus, the investigators will conduct a randomized trial examining Prevention Plus delivered by CHS primary care providers on child zBMI in underserved children receiving their primary care at CHS who are overweight and obese, and test the moderating effect of household food security status on Prevention Plus delivered with and without caretaker goals

Detailed Description

Intervention PP+ Following baseline assessment, children will continue to receive standard care at CHS and the monthly newsletter. Additionally, each family will be provided with a scale; wall growth chart to measure height; a BMI wheel to calculate BMI; a BMI-for-age growth chart; a binder for intervention materials; a self-monitoring diary to record child's monthly height, weight, BMI and BMI percentile; and picture-based diaries to monitor daily energy balance behaviors. Family materials provided at each session will outline a process to measure growth and include information about how children grow, as well as cover behavioral parenting strategies to assist with changing child behavior for energy balance behaviors. Families will meet in person with a BHC at the CHS clinic in which they receive care for 30 minutes during months 1, 3, and 5. In these sessions, child height and weight will be taken, and BMI will be plotted on the BMI-for-age growth chart. Families will receive feedback about growth and the weight status of their child. Additionally, the session materials will be reviewed and behavioral parenting strategies will be encouraged to aid with changing two dietary and two leisure-time activity (energy balance) behaviors of the child. As is traditional in a family-based approach, the caretaker will also change the same energy balance behaviors as the child, as adult caretakers can then model healthy behaviors for the child, assisting the child in learning the new weight-related behaviors.13 Thus, both the caretaker and child will be encouraged to change and self-monitor energy balance behaviors with the use of the picture-based diaries. During months 2, 4, and 6, BHCs will complete a 20-minute phone call with the caretaker. Caretakers will be asked to measure the height and weight of their child, calculate BMI and plot it on the BMI-for-age growth chart prior to the call. During the call, the BHC will provide feedback on the changes in child growth since the previous contact. Additionally, the BHC will discuss the family's progress on achieving child and caretaker energy balance behavior goals and implementation of behavioral parenting strategies. The child's energy balance behavioral goals will be to consume \< 3 sugar-sweetened beverage (e.g., regular carbonated soft drinks, sports drinks, lemonades, ice teas, flavored milk, juice drinks \< 100% juice, and punches) servings /wk, ≥1 ½ cups/day of whole vegetables and ≥ 1 cup/day of whole fruit, engage in ≥ 60 minutes/day of moderate- to vigorous-intensity physical activity, and reduce TV viewing to \< 2 hours/day. The caretaker's energy balance behavioral goals will be to consume \< 3 sugar-sweetened beverage servings/wk, ≥ 2 ½ cups/day of whole vegetables and ≥ 1 ½ cups/day of whole fruit, engage in ≥ 150 minutes of moderate- to vigorous-intensity physical activity per week, and reduce TV viewing to \< 10 hours/wk. To increase self-efficacy, the goals will be incrementally increased, with families implementing the full program goals at month four. Additionally, children and caretakers will be asked to achieve at least three of the five goals each day (child) or week (adult caretaker). PP- This condition will be identical to PP+ except that caretakers will not receive any energy balance behavior goals. Additionally, the caretaker will not self-monitor energy balance behaviors. The focus will be on all other behavioral parenting strategies to assist the child with making changes in the targeted behaviors (i.e., stimulus control, positive reinforcement, and assisting child in self-monitoring energy-balance behaviors).

Registry
clinicaltrials.gov
Start Date
April 2016
End Date
November 30, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
The University of Tennessee, Knoxville
Responsible Party
Principal Investigator
Principal Investigator

Hollie Raynor

Professor

The University of Tennessee, Knoxville

Eligibility Criteria

Inclusion Criteria

  • patient at five clinics (Alcoa \[Blount County\], Knox County Pediatrics \[Knox County\], Maynardville \[Union County\], Seymour \[Sevier County\], and Talbott \[Hamblen County\]).
  • BMI \> 85th percentile
  • have an adult (\> 18 years) female caretaker living in the household willing to participate in the program.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Target Population Denominator

Time Frame: 2 years

CHS' Electronic Health Record will allow the number of children meeting eligibility criteria to be determined and the target population denominator identified.

Household Food Security Status assessed with the Household Food Security Module

Time Frame: Baseline

This module consists of three stages of adult-referenced questions and two stages of child-referenced questions. The time frame that will be used to assess household food security status will be in the previous 30 days (the module is validated for a 12-month or 30 day time frame). Families will be scored as food secure (high and marginal household food security) or food insecure (low and very low household food security). This will be administered at 0 and 6 months (to assess if household food security status changed during the intervention).

Activity assessed via Previous Day Physical Activity Recall

Time Frame: Change from baseline to 6 months

This is a self-report questionnaire that assesses all activity, both physical activity and sedentary behavior, in children and adolescents. Specifically, the PD-PAR collects information on screen time, allowing measurement of this targeted behavior. This questionnaire will be completed at 0 and 6 by both children and caretakers. The compendium of physical activities for youth will be used to estimate energy expenditure from the PD-PAR. Dependent variables will be minutes of physical activity and screen time, percent of time spent in sedentary behavior and moderate- to vigorous-intensity physical activity, and overall daily metabolic equivalent (MET) value.

z-BMI

Time Frame: Change from baseline to 6-months

Parent Weight History

Time Frame: baseline

parent weight loss history will be obtained via a questionnaire

Basic demographic information and weight history

Time Frame: Baseline

Basic demographic information (e.g., child's gender and age; parent's, gender, age, and education level) and health history will be obtained at baseline.

Child and caretaker dietary intake be assessed via 3-day food diaries

Time Frame: Change from baseline to 6 months

During the 3-day period(1 weekend day, 2 weekdays), if the child is under the supervision/care of another adult other than the caretaker, the caretaker will be instructed to obtain information from this other adult about what the child consumed. Families will be provided with measuring cups and spoons and two-dimensional aids to help with accuracy of recording. Caretakers will be trained on how to complete the food diaries. Diaries will be reviewed to ensure that information about food consumption is complete. Nutrition data will be analyzed using the Nutrition Data System Research Software (NDSR)

Quality Control

Time Frame: 2 years

Secondary Outcomes

  • Participation Rate(2 years)
  • program sustainability assessed via interviews(2 years)
  • Participant vs. non-participant Characteristics(2 years)
  • Program Adherence assessed with a a behavioral checklist(2 years)
  • Intervention Fidelity assessed with a behavioral checkllist(2 years)

Study Sites (1)

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