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

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ClinicalTrials.gov Identifier: NCT02684214
Recruitment Status : Active, not recruiting
First Posted : February 17, 2016
Last Update Posted : November 16, 2020
Sponsor:
Collaborators:
Cherokee Health Systems
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Hollie Raynor, The University of Tennessee, Knoxville

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 controlled trial (RCT) 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

Condition or disease Intervention/treatment Phase
Obesity Childhood Obesity Behavioral: Prevention Plus + Behavioral: Prevention Plus - Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : April 2016
Actual Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: Food secure families
high and marginal household food security
Behavioral: Prevention Plus +
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.

Behavioral: Prevention Plus -
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.

Experimental: Food insecure families
low and very low household food security
Behavioral: Prevention Plus +
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.

Behavioral: Prevention Plus -
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 Measures :
  1. 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.

  2. 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.

  3. 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).

  4. z-BMI [ Time Frame: Change from baseline to 6-months ]
  5. 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)

  6. 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.

  7. Quality Control [ Time Frame: 2 years ]
  8. Parent Weight History [ Time Frame: baseline ]
    parent weight loss history will be obtained via a questionnaire


Secondary Outcome Measures :
  1. Participation Rate [ Time Frame: 2 years ]
  2. Participant vs. non-participant Characteristics [ Time Frame: 2 years ]
    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.

  3. Program Adherence assessed with a a behavioral checklist [ Time Frame: 2 years ]
    Adherence to delivery of intervention for each session will be ascertained using a behavioral checklist

  4. Intervention Fidelity assessed with a behavioral checkllist [ Time Frame: 2 years ]
    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.

  5. program sustainability assessed via interviews [ Time Frame: 2 years ]

    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.




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Ages Eligible for Study:   4 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02684214


Locations
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United States, Tennessee
Healthy Eating and Activity Laboratory, University of Tennessee
Knoxville, Tennessee, United States, 37996
Sponsors and Collaborators
The University of Tennessee, Knoxville
Cherokee Health Systems
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Publications:

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Responsible Party: Hollie Raynor, Professor, The University of Tennessee, Knoxville
ClinicalTrials.gov Identifier: NCT02684214    
Other Study ID Numbers: UTK IRB-15-02680-FB
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: November 16, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Hollie Raynor, The University of Tennessee, Knoxville:
food security
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight