Healthy Kids & Families: Overcoming Social, Environmental and Family Barriers to Childhood Obesity Prevention

NCT03028233 — Not applicable, Completed, 244 participants, University of Massachusetts, Worcester

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  
RegistryNCT03028233
StatusCompleted
PhaseNot applicable
Study typeInterventional; non randomized, parallel, masking: none, prevention
Enrollment244 (Actual)
SponsorUniversity of Massachusetts, Worcester (Other); collaborators: Oak Hill Community Development Corporation, Worcester Public Schools
ConditionsObesity
InterventionsHealthy Lifestyle, Positive Parenting (Behavioral)
Datesstart 2014-09-01, primary completion 2019-04-22, completion 2019-04-22, first posted 2017-01-23, last updated 2019-05-03
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Obesity All trials of Healthy Lifestyle All trials of Positive Parenting

-Summary

The study will test the impact of a community health worker (CHW)-delivered intervention aimed at helping families overcome barriers to childhood obesity prevention. Barriers include social, environmental, and family issues.

This intervention will be compared to a control condition consisting of a community health worker (CHW)-delivered intervention aimed at helping families improve positive parenting skills.

Expand all sections  ·  Collapse all

+Detailed description

The study will test the impact of a community health worker (CHW)-delivered intervention aimed at helping families overcome barriers to childhood obesity prevention. Barriers include social, environmental, and family issues.

This intervention will be compared to a control condition consisting of a community health worker (CHW)-delivered intervention aimed at helping families improve positive parenting skills.

The intervention uses multiple delivery modalities to maintain novelty and prevent attrition/burden. These include home visits, telephone contacts, print (literacy sensitive newsletters), social media (Facebook), and community events. Parents and children will complete scheduled assessments at baseline, 6-, 12-, 18- and 24-month follow-up.

The Specific Aims are:

Aim 1: To determine the effectiveness of the intervention compared to the control condition on child physical activity, healthy eating, BMI and utilization of built environment resources.

Aim 2: To determine the effectiveness of the intervention compared to the control condition on parent physical activity, healthy eating, BMI.

Aim 3: To examine the potential scalability of the intervention guided by the RE-AIM (Reach Effectiveness Adoption Implementation Maintenance) model.

+Arms and interventions

ArmTypeInterventionsDescription
Healthy LifestylesExperimentalBehavioral: Healthy LifestyleThe study will test the impact of a community health worker (CHW)-delivered intervention aimed at helping families overcome barriers to childhood obesity prevention. Barriers include social, environmental, and family issues.
Positive ParentingActive comparatorBehavioral: Positive ParentingThe control condition consists of a community health worker (CHW)-delivered intervention aimed at helping families improve positive parenting skills.
  • Healthy Lifestyle (Behavioral): A Community Health Worker coaches families regarding healthy eating, physical activity, and obesity prevention, and promotes the use of existing built environment resources.
  • Positive Parenting (Behavioral): A Community Health Worker coaches parents on improving positive parenting skills and promotes the use of relevant community resources.

+Outcome measures

Primary outcomes

  • child BMI z-score [2 years]: Weight and height is measured using standard methodology, with children wearing light clothing and no shoes. Weight is measured to the nearest 0.5 lb on a digital scale. Height is measured to the nearest tenth of a centimeter using a stadiometer. BMI is calculated: weight (kg)/height squared (meters) for age and gender using United States Centers for Disease Control and Prevention BMI charts growth charts.

Secondary outcomes

  • Child Dietary Behaviors: Overall [2 years]: This Outcome Measure is assessed through the following measure, modified for verbal administration: Selected items from the Massachusetts Parent Child Longitudinal Cohort Survey (Taveras et al., MA-CORD Study Group)
  • Child Dietary Behaviors for snacks [2 years]: This Outcome Measure is assessed through the following measure, modified for verbal administration:Snack items from the Beverage and Snack Questionnaire2 (BSQ2) (https://sharedresources.fredhutch.org/documents/beverage-and-snack-questionnaire-2)
  • Child Dietary Behaviors for Beverages [2 years]: This Outcome Measure is assessed through the following measure, modified for verbal administration: Beverage Intake Questionnaire (Hedrick et al)
  • Parent Dietary Behaviors: Overall [2 years]: This Outcome Measure is assessed through the following measure, modified for verbal administration: Selected items from the Massachusetts Parent Child Longitudinal Cohort Survey (Taveras et al., MA-CORD Study Group)
  • Parent Dietary Behaviors for Snacks [2 years]: This Outcome Measure is assessed through the following measure, modified for verbal administration: Snack items from the Beverage and Snack Questionnaire2 (BSQ2) (https://sharedresources.fredhutch.org/documents/beverage-and-snack-questionnaire-2)
  • Parent Dietary Behaviors for Beverages [2 years]: This Outcome Measure is assessed through the following measure, modified for verbal administration: Beverage Intake Questionnaire (Hedrick et al)
  • Child Physical Activity and Sedentariness: Massachusetts Parent Child Longitudinal Cohort Survey [2 years]: This Outcome Measure is assessed through the following measure, modified for verbal administration: Selected items from the Massachusetts Parent Child Longitudinal Cohort Survey (Taveras et al., MA-CORD Study Group)
  • Child Physical Activity and Sedentariness: C-PAQ and PAQ-C [2 years]: This Outcome Measure is assessed through the following measure, modified for verbal administration:Selected items from the Physical Activity C-PAQ (Kemper et al) plus PAQ-C (Kowalski et al) activity questions
  • Child Physical Activity and Sedentariness: ActiGraph GT1M [2 years]: Child physical activity and sedentariness are measured by the child wearing the ActiGraph Model GT1M for 7 days averaged. This measure provides data on intensity and duration of activities.
  • Parent physical activity and sedentariness: Massachusetts Parent Child Longitudinal Cohort Survey [2 years]: This Outcome Measure is assessed through the following measure, modified for verbal administration:Selected items from the Massachusetts Parent Child Longitudinal Cohort Survey (Taveras et al., MA-CORD Study Group)
  • Parent physical activity and sedentariness: C-PAQ and PAQ-C [2 years]: This Outcome Measure is assessed through the following measure, modified for verbal administration: Selected items from the Physical Activity C-PAQ (Kemper et al) plus PAQ-C (Kowalski et al) activity questions
  • Parent physical activity and sedentariness: ActiGraph GT1M [2 years]: Parent physical activity and sedentariness are measured by the parent wearing the ActiGraph Model GT1M for 7 days averaged. This measure provides data on intensity and duration of activities
  • Parent BMI [2 years]: BMI is calculated with weight and height measurements using standard methodology. Weight is measured to the nearest 0.5 lb on a digital scale. Height is measured to the nearest centimeter using a stadiometer. BMI is calculated: weight (kg)/height squared (meters) for gender using United States Centers for Disease Control and Prevention BMI charts.
  • Child utilization of built environment resources [2 years]: Child utilization of built environment resources is assessed by the children wearing a portable GPS unit (\~size of a matchbox) when wearing an accelerometer. The GPS unit records the geographic coordinates of the child's activities. Measures of frequency and duration of activities by neighborhood space (e.g., parks) can be ascertained.

+Eligibility

Sex: All, ages: 4 Years to any, accepts healthy volunteers

Inclusion Criteria:

* Eligible individuals for the research study are parents/guardians and their K-6th grade children attending one of 9 schools in the greater Worcester area. Parents and their children are recruited as parent-child dyads.

Exclusion Criteria:

* Has an inability or unwillingness to give informed consent or assent
* Is a prisoner

Exclusion (child only)

* The child has been told by a doctor that they cannot walk or eat fruits and vegetables.

+Locations (1)

FacilityCityCountryStatus
UMass Medical SchoolWorcester, MassachusettsUnited States

+Publications

  • Results publication: Borg A, Haughton CF, Sawyer M, Lemon SC, Kane K, Pbert L, Li W, Rosal MC. Design and methods of the Healthy Kids & Families study: a parent-focused community health worker-delivered childhood obesity prevention intervention. BMC Obes. 2019 Jun 3;6:19. doi: 10.1186/s40608-019-0240-x. eCollection 2019. PMID 31171975

+Investigators

+Funding

NIH grants: U48DP005031