Family Matters Intervention

Childhood Obesity Clinical Trial

Official title: Reducing Childhood Obesity Using Ecological Momentary Intervention (EMI) and Video Feedback at Family Meals

Status Enrolling by invitation

Clinical Trial Summary

The proposed study is a 12-month, individual randomized controlled trial (RCT). The main aim of the study is to decrease childhood obesity (BMI percentile, neck circumference) and improve child diet quality in children ages 5-10 years old by increasing family meal quality (i.e., dietary intake, interpersonal atmosphere) and quantity (i.e., frequency of family meals) via innovative technology (i.e., ecological momentary intervention (EMI), video feedback) and partnerships with primary care and Community Health Workers (CHWs).

Clinical Trial Description

The RCT has the following three arms: (1) Ecological Momentary Intervention (EMI); (2) EMI + HV + Video feedback (virtual); (3) EMI + HV + Video feedback (hybrid). Delivery of the intervention will last 6 months for each family, with a 6-month post-intervention evaluation visit. All arms will receive EMI family meal tips via smartphones for 16 weeks. Arms 2 and 3 will also receive 16 weeks of in-home training (arm 2 will be virtual, arm 3 will be hybrid virtual/in-home), with 8 weeks (every other week) in-home education visits with a CHW focused on family meal quality and quantity and a family meal preparation activity and 8 weeks "Try it Yourself" activities that reinforce the messages and skills taught by a CHW. Additionally, Arms 2 and 3 will receive video feedback from family's video-recorded family meals by a CHW focusing on family behaviors related to family meal quality and quantity. (EMI, in-home training, and video-feedback will occur during the same 16-week period.) After families have completed 16 weeks of the intervention, a 8-week maintenance phase will ensue. Having a maintenance phase is an evidence-based intervention component and will provide incrementally less support to families to build self-efficacy and increase sustainability of new behaviors. Over time, participants will receive less study support to evaluate if participants have internalized healthful behaviors. During the maintenance phase EMI meal tips will be reduced to only the days in which parents report their highest stress levels for all arms. The study will last 12 months, with three assessment time points including, baseline, 6 months (i.e., post-intervention) and 12 months.

Children ages 5-10 and family members (i.e., parent/primary caregiver, siblings) from low-income and diverse households (i.e., African American, Asian, Hispanic, Native American, White) - who are at high risk for obesity - will be recruited for the study. Theory informs the intervention study design, research questions and related hypotheses, methods, measurement, and analysis. Family Systems Theory drives the decision to direct the intervention at the "family unit" to increase the likelihood of individual and family-level weight and weight-related behavior change and sustainability. Additionally, partnerships with existing community-based healthcare systems and CHWs will be utilized to reach participants in community settings where they have existing relationships and resources.

This study utilizes innovative and research-informed intervention components (i.e., in-home visiting, EMI, video-feedback) to increase the likelihood of intervention effectiveness and sustainability. The "Family Matters" study will be carried out across two Phases, an R61 Phase and an R33 Phase. Specific aims for each Phase are described below:

Specific Aims for the R61 Phase:

• Aim 1 (Primary Outcomes): Conduct a three-arm RCT comparing EMI, EMI+HV, and EMI+HV+Video Feedback in diverse children ages 5-10 and their families to test the hypotheses that:

Hypothesis 1: BMI percentile and neck circumference will decrease and diet quality will increase in children in the EMI+HV+Video Feedback hybrid arm compared to children in the EMI or virtual-only arms.

• Aim 2 (Secondary Outcomes): Examine intervention effects on familial, parental, and sibling factors.

Hypothesis 1: Family meal quality and quantity will increase in households with children in the EMI+HV+ Video Feedback hybrid arm compared to children in the EMI or virtual arms.

Hypothesis 2: Controlling feeding practices (e.g., restriction) will decrease and coping skills will increase in parents in the EMI+HV+Video Feedback hybrid arm compared to parents in the EMI or virtual arms.

Hypothesis 3: BMI percentile will decrease in siblings in the EMI+HV+Video Feedback hybrid arm compared to siblings in the EMI or virtual arms.

• Aim 3: Examine cost effectiveness and feasibility of intervention implementation in primary care.

Hypothesis 1: The BMI z-score and neck circumference reduction resulting from the intervention will be cost-effective. ;

Related Conditions & MeSH terms

• Childhood Obesity
• Obesity
• Pediatric Obesity

• NCT number: NCT02669797
• Study type: Interventional
• Source: University of Colorado, Denver
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 11, 2022
• Completion date: April 30, 2027