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Family Matters Intervention

University of Colorado Denver (CU Denver) logo

University of Colorado Denver (CU Denver)

Status

Invitation-only

Conditions

Childhood Obesity

Treatments

Behavioral: Maintenance
Behavioral: Feedback on Video-recorded Family Meals
Behavioral: In-home Visits and Food Preparation Activities
Behavioral: Ecological Momentary Intervention

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02669797
FMCH-2017-25964

Details and patient eligibility

About

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).

Full 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.

Enrollment

500 estimated patients

Sex

All

Ages

5 to 10 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

STUDY INCLUSION CRITERIA

The inclusionary criteria used to select participants for the proposed study includes:

  1. Boys and girls (n=500) ages 5-10 years old who attend a University of Minnesota Physicians (n=4) or Fairview (n=8) primary care clinic and their primary caregiver (e.g., mother, father, grandparent) and at least one sibling. A second primary caregiver and other family members can also participate.
  2. Must eat ≤3 family dinner meals per week. Research shows that youth who have more than three family meals per week are less likely to be obese ten years later. Thus, families who report three or fewer family meals per week will be recruited to optimize the potential for change in family meal frequency. Families will focus on the family dinner in the intervention to improve their family meal quality and quantity. This decision is based on: (1) Family Systems Theory, which indicates that change in one setting (e.g., family dinner) will generalize to other settings (e.g., breakfast, lunch, snacks).
  3. Child with age and sex adjusted BMI ≥75th percentile (no upper limit).
  4. One of the following race/ethnicities: African American, Asian, Hispanic/Latino, Native American, Asian American, or White. In order to examine racial/ethnic differences in study hypotheses, equal numbers of children per racial/ethnic group (total=500) will be recruited.
  5. Parent and family members who speak English or Spanish.
  6. Not expected to move within the next two years.

STUDY EXCLUSION CRITERIA

The exclusionary criteria used to exclude participants from the proposed study includes:

  1. Children with medically necessary dietary restrictions (reviewed by MD from primary care clinics).
  2. Non-custodial parents, who the child does not live with more than 50% of the time.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

500 participants in 3 patient groups

EMI
Experimental group
Description:
EMI (Arm 1): (1) tailored ecological momentary intervention (EMI) prompts sent to parents targeting momentary behaviors (e.g., stress) around family meal quality and quantity for 16 weeks; and (2) a 8-week maintenance phase with EMI tips delivered on high stress days.
Treatment:
Behavioral: Ecological Momentary Intervention
Behavioral: Maintenance
EMI + HV + Video feedback, Virtual
Experimental group
Description:
EMI + HV + Video Feedback (Arm 2) education visits will all be delivered virtually, and the arm includes: (1) tailored ecological momentary intervention (EMI) prompts sent to parents targeting momentary behaviors (e.g., stress) around family meal quality and quantity for 16 weeks; (2) bi-weekly in-home educational visits (total of 8) with a community health worker (CHW) focusing on family meal quality (i.e., dietary quality, interpersonal quality) and quantity (i.e., frequency of family meals), and 8 weeks "Try it Yourself" activities that reinforce the messages and skills taught by a CHW (for a total of 16 weeks); (3) video feedback on a video-taped family meal delivered every other week during the in-home visit with the CHW; (4) a 8-week maintenance phase with EMI tips delivered on high stress days.
Treatment:
Behavioral: Ecological Momentary Intervention
Behavioral: In-home Visits and Food Preparation Activities
Behavioral: Maintenance
EMI + HV + Video feedback, Hybrid
Experimental group
Description:
EMI + HV + Video Feedback (Arm 3) education visits will be delivered virtually and in-home, and the arm includes: (1) tailored ecological momentary intervention (EMI) prompts sent to parents targeting momentary behaviors (e.g., stress) around family meal quality and quantity for 16 weeks; (2) bi-weekly in-home educational visits (total of 8) with a community health worker (CHW) focusing on family meal quality (i.e., dietary quality, interpersonal quality) and quantity (i.e., frequency of family meals), and 8 weeks "Try it Yourself" activities that reinforce the messages and skills taught by a CHW (for a total of 16 weeks); (3) video feedback on a video-taped family meal delivered every other week during the in-home visit with the CHW; (4) a 8-week maintenance phase with EMI tips delivered on high stress days.
Treatment:
Behavioral: Ecological Momentary Intervention
Behavioral: In-home Visits and Food Preparation Activities
Behavioral: Feedback on Video-recorded Family Meals
Behavioral: Maintenance

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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