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The Bennett Kids PowerUP Project

Primary Purpose

Obesity, Childhood, Type2diabetes

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bennett Kids PowerUP Project
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity, Childhood focused on measuring Rural Population, Child Health, Physical Activity, Healthy Diet, Veggie Meter, Family-based Approach

Eligibility Criteria

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

Inclusion Criteria: 7-to-10-years-old Living in the area of Bennett, Colorado English- or Spanish-speaking Has 1 parent or primary caregiver willing to actively participate Exclusion Criteria: Medical diagnosis of diabetes Serious child or parent health concerns that would interfere with participation Plans to move out of the area during the study period Lives with another child who previously participated in the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention Group

    Control Group

    Arm Description

    Intervention participants will receive approximately 25 hours of programming (over a 6-month period) related to the promotion of physical activity and healthy diet through: 16 self-contained, parent-guided activity kits, 9 one-on-one health coach/support sessions in-person or virtual by a trained health coach, unlimited access to a resource toolbox.

    Control group programming consists of: 6 parent-guided activity kits focused on STEM activities, 6 monthly check-in calls to support retention. The investigators will use Home Science Lab STEM kits designed for English- and Spanish-speaking children aged 6-11 years. The STEM kits do not include any physical health content. Kits will be mailed monthly to the participants' home. To maximize retention in the control group, staff will contact participants each month to confirm the kit was received, encourage completion of the kits, ask about their experience, and answer questions.

    Outcomes

    Primary Outcome Measures

    Change from Baseline Dietary Intake at 7 months
    Diet will be assessed with 24-hour dietary recalls using the Automated SelfAdministered system (ASA24). This system uses the USDA multiple-pass method to query all foods and supplements consumed in the prior 24 hours and produces daily and individual food estimates for macronutrients, micronutrients, and MyPyramid Equivalents (such as servings of vegetables, fruits, whole grains, solid fats, and added sugars).
    Change from Baseline Fruit and Vegetable Intake at 7 months
    Use the VeggieMeter (Longevity Link, Salt Lake City, UT) to assess carotenoids, a biomarker of fruit and vegetable intake. The device estimates total dermal carotenoid concentration by illuminating the fingertip with a blue wavelength laser light and detecting vibrational/rotational energy levels of molecules, correcting for hemoglobin and melanin levels.
    Change from Baseline Sugar-Sweetened Beverage Intake at 7 months
    Collect red blood cells to measure the carbon isotope ratio, a biomarker of sugar-sweetened beverage intake. Samples will be analyzed via continuous-flow isotope ratio mass spectrometry at the University of Alaska Stable Isotope Facility.

    Secondary Outcome Measures

    Change from Baseline Physical Activity at 7 months
    7-day accelerometry using the wGT3X-BT water resistant tri-axial accelerometer (Actigraph LLC, Pensacola, FL). Monitors are worn on an elastic band on the waist for 7 days. Recordings with greater than or equal to 10 hours of data on 4 or more days will be coded using established youth cut-points to determine the daily minutes of moderate-vigorous activity and sedentary time.
    Change from Baseline Screen Time at 7 months
    CommonSense Media Use Survey to estimate minutes/day across relevant categories (e.g. recreational use vs communication vs educational). Our screen time analyses will focus on recreational screen time but also report on the other types.

    Full Information

    First Posted
    March 16, 2023
    Last Updated
    September 11, 2023
    Sponsor
    University of Colorado, Denver
    Collaborators
    American Diabetes Association
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05858580
    Brief Title
    The Bennett Kids PowerUP Project
    Official Title
    Pilot Study of a Home-based Program to Promote Healthy Diet and Activity in Rural-dwelling Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    June 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Colorado, Denver
    Collaborators
    American Diabetes Association

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The study proposes a randomized pilot and feasibility study of a lifestyle modification program to promote healthy diet and activity in rural-dwelling children to reduce Type 2 Diabetes risks. Intervention participants will receive 6 months of programming to include: 16 activity packs; 9 health coach sessions; unlimited access to a resource toolbox. Control participants will receive 6 activity packs promoting science, technology, engineering, and math (STEM) learning and 6 check-in calls to support retention. Our specific aims are: Determine reach, feasibility, and acceptability of our intervention and a complementary control program in a randomized pilot study. Estimate the magnitude of the intervention's effect on diet, activity, and metabolic risk factors. Engage partners from additional rural communities to scale and evaluate the intervention in a clinical trial.
    Detailed Description
    The rising prevalence of obesity and type 2 diabetes (T2D) at increasingly younger ages compels development of new strategies to combat these preventable conditions. Healthy diet and activity are critical to reducing risk, yet these behaviors decline starting in childhood. These trends are most troubling in rural areas, where youth consume more calories and sugar-sweetened beverages but less fruit and whole grains; engage in less physical activity; and are more likely to have overweight or obesity than urban peers. Given unhealthy behaviors are set by adolescence, promoting healthy diet and activity in rural children is crucial to reducing rural-urban disparities in obesity and T2D across the lifecourse. The investigators have developed a multi-component, family-based intervention to improve diet and activity in children at risk of youth-onset obesity and T2D. The pilot study will gather necessary and sufficient data on feasibility, acceptability, and effect size to finalize the design of a clinical trial. The investigators will recruit 60 English- or Spanish-speaking children in 2nd to 5th grades from a rural community in Colorado. Participants will be randomized to 6 months of intervention or control programming. Intervention participants will receive approximately 25 hours of programming over 6 months through a) 16 self-contained, parent-guided activity kits, b) 9 one-on-one health coach/support sessions in-person or virtual by a trained health coach, and c) unlimited access to a resource toolbox. Control participants will receive 6 activity kits promoting science, technology, engineering, and math (STEM) learning and will receive 6 check-in calls to support retention. Standardized measures will be collected at 0 and 7 months. Qualitative interviews will also be conducted at 7 months. Process measures will be tracked by staff throughout the study. With positive results, this innovative pilot study will form the foundation of a clinical trial to evaluate the sustained impact of an at-home, family-based intervention to promote diet and activity in rural children, which can subsequently be disseminated and implemented among the 13 million children living in rural US settings and reduce T2D risks.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Childhood, Type2diabetes
    Keywords
    Rural Population, Child Health, Physical Activity, Healthy Diet, Veggie Meter, Family-based Approach

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Participants will be randomized 1:1 in blocks of 6 to the intervention or control groups with the Randomization Module of the Research Data Capture (REDCap).
    Masking
    Outcomes Assessor
    Masking Description
    Data collectors will be blinded to the participant's assigned group.
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention Group
    Arm Type
    Experimental
    Arm Description
    Intervention participants will receive approximately 25 hours of programming (over a 6-month period) related to the promotion of physical activity and healthy diet through: 16 self-contained, parent-guided activity kits, 9 one-on-one health coach/support sessions in-person or virtual by a trained health coach, unlimited access to a resource toolbox.
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    Control group programming consists of: 6 parent-guided activity kits focused on STEM activities, 6 monthly check-in calls to support retention. The investigators will use Home Science Lab STEM kits designed for English- and Spanish-speaking children aged 6-11 years. The STEM kits do not include any physical health content. Kits will be mailed monthly to the participants' home. To maximize retention in the control group, staff will contact participants each month to confirm the kit was received, encourage completion of the kits, ask about their experience, and answer questions.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Bennett Kids PowerUP Project
    Intervention Description
    Information targeting dietary and activity behaviors while also identifying and addressing barriers to permanent lifestyle change. The foundation of the curriculum is the Diabetes Prevention Program Lifestyle Balance and its subsequent adaptations for non-Native adult, Native adult, and Native child populations.
    Primary Outcome Measure Information:
    Title
    Change from Baseline Dietary Intake at 7 months
    Description
    Diet will be assessed with 24-hour dietary recalls using the Automated SelfAdministered system (ASA24). This system uses the USDA multiple-pass method to query all foods and supplements consumed in the prior 24 hours and produces daily and individual food estimates for macronutrients, micronutrients, and MyPyramid Equivalents (such as servings of vegetables, fruits, whole grains, solid fats, and added sugars).
    Time Frame
    Baseline (0 months) and Post-intervention (7 months)
    Title
    Change from Baseline Fruit and Vegetable Intake at 7 months
    Description
    Use the VeggieMeter (Longevity Link, Salt Lake City, UT) to assess carotenoids, a biomarker of fruit and vegetable intake. The device estimates total dermal carotenoid concentration by illuminating the fingertip with a blue wavelength laser light and detecting vibrational/rotational energy levels of molecules, correcting for hemoglobin and melanin levels.
    Time Frame
    Baseline (0 months) and Post-intervention (7 months)
    Title
    Change from Baseline Sugar-Sweetened Beverage Intake at 7 months
    Description
    Collect red blood cells to measure the carbon isotope ratio, a biomarker of sugar-sweetened beverage intake. Samples will be analyzed via continuous-flow isotope ratio mass spectrometry at the University of Alaska Stable Isotope Facility.
    Time Frame
    Baseline (0 months) and Post-intervention (7 months)
    Secondary Outcome Measure Information:
    Title
    Change from Baseline Physical Activity at 7 months
    Description
    7-day accelerometry using the wGT3X-BT water resistant tri-axial accelerometer (Actigraph LLC, Pensacola, FL). Monitors are worn on an elastic band on the waist for 7 days. Recordings with greater than or equal to 10 hours of data on 4 or more days will be coded using established youth cut-points to determine the daily minutes of moderate-vigorous activity and sedentary time.
    Time Frame
    Baseline (0 months) and Post-intervention (7 months)
    Title
    Change from Baseline Screen Time at 7 months
    Description
    CommonSense Media Use Survey to estimate minutes/day across relevant categories (e.g. recreational use vs communication vs educational). Our screen time analyses will focus on recreational screen time but also report on the other types.
    Time Frame
    Baseline (0 months) and Post-intervention (7 months)
    Other Pre-specified Outcome Measures:
    Title
    Change from Baseline Glucose at 7 months
    Description
    Fasting serum samples analysis (Hexokinase, UV)
    Time Frame
    Baseline (0 months) and Post-intervention (7 months)
    Title
    Change from Baseline Insulin at 7 months
    Description
    Fasting serum samples analysis (chemiluminescence immunoassay)
    Time Frame
    Baseline (0 months) and Post-intervention (7 months)
    Title
    Change from Baseline BMI at 7 months
    Description
    Measured height, weight
    Time Frame
    Baseline (0 months) and Post-intervention (7 months)
    Title
    Program Engagement
    Description
    Report of activity kits completed
    Time Frame
    Post-intervention (7 months)
    Title
    Completion of coaching sessions
    Description
    Report on health coach sessions completed
    Time Frame
    Post-intervention (7 months)
    Title
    Use of toolbox
    Description
    Report on frequency of use of the resource toolbox
    Time Frame
    Post-intervention (7 months)
    Title
    Process Measures
    Description
    Staff records of the actual schedule (order and timing) of mailed activity kits and health coach sessions
    Time Frame
    Baseline (0 months) and Post-intervention (7 months)
    Title
    Acceptability and Engagement Barriers
    Description
    Semi-structured interviews
    Time Frame
    Post-intervention (7 months)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Years
    Maximum Age & Unit of Time
    10 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 7-to-10-years-old Living in the area of Bennett, Colorado English- or Spanish-speaking Has 1 parent or primary caregiver willing to actively participate Exclusion Criteria: Medical diagnosis of diabetes Serious child or parent health concerns that would interfere with participation Plans to move out of the area during the study period Lives with another child who previously participated in the study
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Study Coordinator
    Phone
    720-957-5074
    Email
    bennettkids@cuanschutz.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Katherine A Sauder, PhD
    Organizational Affiliation
    University of Colorado School of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    The Bennett Kids PowerUP Project

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