Family Matters Intervention

Last updated on July 2021

Recruitment

Recruitment Status: Not yet recruiting
Estimated Enrollment: 200

Summary

Conditions: Childhood Obesity
Type: Interventional
Phase: Not Applicable
Design: Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Three-arm, individual randomized controlled trial.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Like most behavioral interventions, it is not possible to double blind this RCT because interventionists will be delivering the in-home visiting components to participants. However, the proposed study incorporates participant, study staff, physician, and investigator blinding as much as possible. The intervention will be administered by trained staff assigned to the intervention team, who will not be involved with evaluation team responsibilities/meetings. Evaluation team members will carry out all measurement home visits and will be blinded to participant study arm assignment. They will not be involved with intervention team responsibilities/meetings. Specific co-investigators are responsible for training and supervising staff within the intervention team versus the evaluation team in to order to blind as many co-investigators as possible.Primary Purpose: Treatment

Participation Requirements

Age: Between 5 years and 8 years
Gender: Both males and females

Description

The RCT has the following three arms: (1) Ecological Momentary Intervention (EMI); (2) EMI + Home Visiting (HV); (3) EMI + HV + Video feedback. 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, 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, Arm 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 5-8 and family members (i.e., parent/primary caregiver, siblings) from low-income and diverse households (i.e., African American, 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: Organize and prepare the study team, project materials, study protocols, and procedures. Aim 1 success will be measured by meeting established R61 Planning Phase transition milestones. Aim 2: Test recruitment, data collection, intervention protocols, and retention in the first 42 participants (4 per study arm and about equal numbers byrace/ethnicity). Aim 2 success will be measured by meeting transition milestones. Specific Aims for the R33 Phase: • Aim 1 (Primary Outcomes): Conduct a three-arm RCT comparing EMI, EMI+HV, and EMI+HV+Video Feedback in diverse children ages 5-8 and their families to test the hypotheses that: Hypothesis 1: BMI percentile will decrease and diet quality will increase in children in the EMI+HV+Video Feedback arm compared to children in the EMI or EMI+HV 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 arm compared to children in the EMI or EMI+HV arms. Hypothesis 2: Controlling feeding practices (e.g., restriction) will decrease and coping skills will increase in parents in the EMI+HV+Video Feedback arm compared to parents in the EMI or EMI+HV arms. Hypothesis 3: BMI percentile will decrease in siblings in the EMI+HV+Video Feedback arm compared to siblings in the EMI or EMI+HV arms. • Aim 3: Examine cost effectiveness and feasibility of intervention implementation in primary care. Hypothesis 1: The BMI z-score reduction resulting from the intervention will be cost-effective.

Tracking Information

NCT #: NCT02669797
Collaborators: Not Provided
Investigators: Not Provided