Clinical trial NCT02684214: Implementing Prevention Plus for Childhood Overweight and Obesity in Food Secure and Insecure Families
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Childhood Obesity
Keywords: food security
Lead sponsor: The University of Tennessee, Knoxville
Sponsor class: OTHER
Collaborators: name: Cherokee Health Systems
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2016-02-17
Enrollment: 73
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Target Population Denominator
timeFrame: 2 years
measure: Basic demographic information and weight history
timeFrame: Baseline
measure: Household Food Security Status assessed with the Household Food Security Module
timeFrame: Baseline
measure: z-BMI
timeFrame: Change from baseline to 6-months
measure: Child and caretaker dietary intake be assessed via 3-day food diaries
timeFrame: Change from baseline to 6 months
measure: Activity assessed via Previous Day Physical Activity Recall
timeFrame: Change from baseline to 6 months
measure: Quality Control
timeFrame: 2 years
measure: Parent Weight History
timeFrame: baseline
Secondary outcomes:
measure: Participation Rate
timeFrame: 2 years
measure: Participant vs. non-participant Characteristics
timeFrame: 2 years
measure: Program Adherence assessed with a a behavioral checklist
timeFrame: 2 years
measure: Intervention Fidelity assessed with a behavioral checkllist
timeFrame: 2 years
measure: program sustainability assessed via interviews
timeFrame: 2 years
Other outcomes:
Locations:
city: Knoxville
country: United States
facility: Healthy Eating and Activity Laboratory, University of Tennessee
state: Tennessee
Study officials:
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