Clinical trial

Family Matters Intervention

Invitation only · Not applicable · 1 countries · Registry ID NCT02669797

Invitation onlyNot applicableInterventional

What this study is about

The proposed study is a 12-month, individual randomized controlled trial (RCT). The main aim of the study is to decrease cardiovascular disease risk (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).

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age5 Years to 10 Years
SexAll
Healthy volunteersAccepted
ConditionChildhood Obesity, Cardiovascular Disease Prevention

Full registry 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 primary care clinic (e.g., pediatrics, family medicine) in Minneapolis or St. Paul metro area, Minnesota or Denver metro area, Colorado and their primary caregiver (e.g., mother, father, grandparent) and any other family members (e.g., sibling, cousin). 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/high risk for cardiovascular disease 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. 2. Non-custodial parents, who the child does not live with more than 50% of the time.

Treatments and study arms

In-home Visits and Food Preparation Activities

Behavioral

Families will participate in eight in-home education activities. The visits will focus on family meal quality (dietary, interpersonal) and quantity (meal frequency) factors found in prior studies to be associated with child weight and weight-related behaviors. Eight of the visits (every other week) will be delivered by a CHW and will last 90 minutes. Additionally, a family meal food preparation activity will occur to help support families in learning skills to increase family meal quality and quantity. On weeks opposite of the in-home education visits with a CHW, families will be given a "Try it Yourself" activity to reinforce the messages (e.g., use family meals as a family connection time) and skills (e.g., recipe that requires families to steam vegetables) taught by the CHW during the in-home education visits.

Ecological Momentary Intervention

Behavioral

Parents will receive daily EMI messages regarding suggestions for increasing meal quality/quantity via a smartphone application, based on the stress level and source of stress they reported earlier in the day. Specifically, parents will receive two push notifications in the morning to report their stress level and type/source of stress (e.g., work, children, finances). Then, based on the reported stress level and source of stress, parents will be texted tips/ideas for carrying out a nutritionally and emotionally healthful family meal the same night, in the face of stress. If parents report no stress on their EMI measure earlier in the day, they will be provided with a menu of options regarding what type of meal tip they would prefer later in the day (e.g., recipe ideas, meal prep tips, mealtime conversation starters. Parents will be able to respond to the EMI messages indicating preferred tips so that EMI tips become more meaningful/relevant to the needs of each family.

Feedback on Video-recorded Family Meals

Behavioral

Parents will video-record and upload via their cellphone one family meal every other week, which will be watched by intervention staff. Using Motivational Interviewing, CHWs will give specific feedback on how to adapt negative mealtime behaviors and provide reinforcement for positive behaviors seen in the videos, based on a validated interpersonal coding tool called the Iowa Family Interaction Rating Scales (IFIRS). Additionally, feedback will be given on the dietary healthfulness of the meal, based on a validated coding tool called the Healthfulness of Meal Index (HOM). After feedback, family members will be taught specific skills to improve their family meal processes and behaviors that vary from food preparation skills, to increasing healthful food options at meals, or role-playing family interactions to improve the emotional atmosphere at the meal. Families will also set SMART goals at each visit regarding family meal quality and quantity.

Maintenance

Behavioral

After 16 weeks, EMI family meal tips for all arms will be reduced to only the days in which parent's report their highest stress levels. Stress profiles will be created for each parent in order to tailor the EMI family meals tips to days in which they experience their highest levels of stress. For example, during the 16-weeks of EMI, a parent may report their highest stress levels on Tuesdays and Thursdays. The stress profile that would be created for the parent during the maintenance phase would include receiving text messages only on Tuesdays and Thursdays. The parent would then receive these EMI family meal tips only on Tuesdays and Thursdays throughout the 8-week maintenance phase..

Primary outcomes

Child BMI percentile12-months post-baseline

Based on Centers for Disease Control and Prevention (CDC) guidelines, child age and sex will be used to calculate an adjusted BMI percentiles. Measured at three time points over 12 months by study staff.

Child Dietary Quality12-months post-baseline

Child three-day, 24-hour dietary recalls will be used to calculate a Healthy Eating Index (HEI) score, which measures overall dietary quality.

Child Neck Circumference12-months post-baseline

Measured neck circumference on child

Study locations

2 locations were listed when this page was built. The first 40 are shown.

University of Colorado Anschutz Medical Campus--ACCORDS🇺🇸 Aurora, Colorado, United States
University of Minnesota--Department of Family Social Science🇺🇸 Minneapolis, Minnesota, United States