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

NCT02684214 | Completed DMC

• 1 other identifier: UTK IRB-15-02680-FB
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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

Conditions

Obesity; Childhood Obesity

Keywords

food security

Outcome Measures

Primary Outcomes (8)

• Target Population Denominator

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

  2 years

• Basic demographic information and weight history

  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.

  Baseline

• Household Food Security Status assessed with the Household Food Security Module

  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).

  Baseline

• z-BMI

  Change from baseline to 6-months

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

  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)

  Change from baseline to 6 months

• Activity assessed via Previous Day Physical Activity Recall

  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.

  Change from baseline to 6 months

• Quality Control

  2 years

• Parent Weight History

  parent weight loss history will be obtained via a questionnaire

  baseline

Secondary Outcomes (5)

• Participation Rate

  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

• program sustainability assessed via interviews

  2 years

Study Arms (2)

Food secure families

EXPERIMENTAL

high and marginal household food security

Behavioral: Prevention Plus +; Behavioral: Prevention Plus -

Food insecure families

EXPERIMENTAL

low and very low household food security

Behavioral: Prevention Plus +; Behavioral: Prevention Plus -

Interventions

Prevention Plus - BEHAVIORAL

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.

Food insecure families; Food secure families

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

Sponsors & Collaborators

• The University of Tennessee, Knoxville: lead
• Cherokee Health Systems: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Healthy Eating and Activity Laboratory, University of Tennessee

Knoxville, Tennessee, 37996, United States

Location

Related Publications (19)

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  PMID: 22245381 BACKGROUND

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MeSH Terms

Conditions

Obesity; Pediatric Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 2, 2016
• First Posted: February 17, 2016
• Study Start: April 1, 2016
• Primary Completion: December 31, 2018
• Study Completion: November 30, 2021
• Last Updated: March 16, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)