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

Primary Purpose

Obesity, Childhood Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prevention Plus +
Prevention Plus -
Sponsored by
The University of Tennessee, Knoxville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring food security

Eligibility Criteria

4 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Healthy Eating and Activity Laboratory, University of Tennessee

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Food secure families

Food insecure families

Arm Description

high and marginal household food security

low and very low household food security

Outcomes

Primary Outcome Measures

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.
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.
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).
z-BMI
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)
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.
Quality Control
Parent Weight History
parent weight loss history will be obtained via a questionnaire

Secondary Outcome Measures

Participation Rate
Participant vs. non-participant Characteristics
The Electronic Health Record (EHR) will allow comparisons on demographic and health characteristics between eligible children who participate vs. those who do not. CHS IT staff will extract these data from the EHR during the last 4 months of the project.
Program Adherence assessed with a a behavioral checklist
Adherence to delivery of intervention for each session will be ascertained using a behavioral checklist
Intervention Fidelity assessed with a behavioral checkllist
Fidelity will be ascertained by discussion of parent goals regarding energy balance behaviors in PP+ and lack of discussion regarding parent goals or changing energy balance behaviors in PP- and/or refocusing session on behavioral parenting strategies as needed.
program sustainability assessed via interviews
Individual interviews will be conducted with at least 2 providers from each participating CHS clinic and all BHCs who delivered the PP programs to ascertain satisfaction with the approach and perceptions of sustainability of the intervention in CHS. It is anticipated that 10 CHS staff and 2 BHCs will be recruited for the 30 minute interview. Dr. Barroso will lead this process. Interview scripts will be developed via an iterative process involving the research team.

Full Information

First Posted
February 2, 2016
Last Updated
March 15, 2022
Sponsor
The University of Tennessee, Knoxville
Collaborators
Cherokee Health Systems, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT02684214
Brief Title
Implementing Prevention Plus for Childhood Overweight and Obesity in Food Secure and Insecure Families
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
November 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Tennessee, Knoxville
Collaborators
Cherokee Health Systems, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood Obesity
Keywords
food security

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Food secure families
Arm Type
Experimental
Arm Description
high and marginal household food security
Arm Title
Food insecure families
Arm Type
Experimental
Arm Description
low and very low household food security
Intervention Type
Behavioral
Intervention Name(s)
Prevention Plus +
Intervention Description
Families will receive 6 monthly newsletters and meet with a BHC at the clinic for 30 minutes during months 1, 3, and 5. Child height and weight will be taken. Families will receive feedback about growth and the weight status of their child. 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. The caretaker will also change the same energy balance behaviors as the child, as adult caretakers can then model healthy behaviors. 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. The BHC will provide feedback.
Intervention Type
Behavioral
Intervention Name(s)
Prevention Plus -
Intervention Description
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.
Primary Outcome Measure Information:
Title
Target Population Denominator
Description
CHS' Electronic Health Record will allow the number of children meeting eligibility criteria to be determined and the target population denominator identified.
Time Frame
2 years
Title
Basic demographic information and weight history
Description
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.
Time Frame
Baseline
Title
Household Food Security Status assessed with the Household Food Security Module
Description
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).
Time Frame
Baseline
Title
z-BMI
Time Frame
Change from baseline to 6-months
Title
Child and caretaker dietary intake be assessed via 3-day food diaries
Description
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)
Time Frame
Change from baseline to 6 months
Title
Activity assessed via Previous Day Physical Activity Recall
Description
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.
Time Frame
Change from baseline to 6 months
Title
Quality Control
Time Frame
2 years
Title
Parent Weight History
Description
parent weight loss history will be obtained via a questionnaire
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Participation Rate
Time Frame
2 years
Title
Participant vs. non-participant Characteristics
Description
The Electronic Health Record (EHR) will allow comparisons on demographic and health characteristics between eligible children who participate vs. those who do not. CHS IT staff will extract these data from the EHR during the last 4 months of the project.
Time Frame
2 years
Title
Program Adherence assessed with a a behavioral checklist
Description
Adherence to delivery of intervention for each session will be ascertained using a behavioral checklist
Time Frame
2 years
Title
Intervention Fidelity assessed with a behavioral checkllist
Description
Fidelity will be ascertained by discussion of parent goals regarding energy balance behaviors in PP+ and lack of discussion regarding parent goals or changing energy balance behaviors in PP- and/or refocusing session on behavioral parenting strategies as needed.
Time Frame
2 years
Title
program sustainability assessed via interviews
Description
Individual interviews will be conducted with at least 2 providers from each participating CHS clinic and all BHCs who delivered the PP programs to ascertain satisfaction with the approach and perceptions of sustainability of the intervention in CHS. It is anticipated that 10 CHS staff and 2 BHCs will be recruited for the 30 minute interview. Dr. Barroso will lead this process. Interview scripts will be developed via an iterative process involving the research team.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Healthy Eating and Activity Laboratory, University of Tennessee
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37996
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Implementing Prevention Plus for Childhood Overweight and Obesity in Food Secure and Insecure Families

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