Strong Families Start at Home/Familias Fuertes Comienzan en Casa
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrown University
About this trial
The goal of this clinical trial is to test the ability of a home-based parental nutrition intervention to improve diet quality in preschool aged children within low-income, Latinx/Hispanic families. The main questions it aims to answer are:
* Does this enhanced intervention change children's diet quality? * Does this enhanced intervention change parental feeding practices? * Does this enhanced intervention change the availability of healthy foods in the home?
Participants will:
* Work with a support coach * Have a home visit with a support coach once a month, for three months * Have a phone call with a support coach once a month, for three months * Receive written materials and text messages over the six months
Researchers will compare a control group receiving different written materials and messages to see if the enhanced intervention changes diet quality in children.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
At least 18 years old
Self-identity as Latinx/Hispanic
Speak English or Spanish
Be the primary caregiver of a child between 2- 5 years of age
Disqualifiers
A doctor or WIC provider has told them that their child was underweight in the past 6 months
The child has a diagnosed feeding disorder or dietary restriction that impacts how they eat
Trial design
Design model
Parallel
Treatments tested in this trial
Home-Based Video and Motivational Interviewing Intervention
BehavioralThe intervention consists of three home-based visits, followed by phone calls during the last three months of the intervention. For each visit and phone call, participants will receive tailored print materials, and during the 6 months of the interventions, they will receive text messages 2x/week. The intervention will be delivered in English or Spanish by a bilingual Community Health Worker (CHW). The CHW will be hired to serve as MI counselors for the parents in the study, and will be in charge of delivering the MI in-home or telephone sessions. CHWs will be trained for 3 months, in Motivational Interviewing, study protocols, the use of video recordings, meal preparation, and cooking, and will undergo a MI certification process. During the sessions with the participants, the CHW will deliver semi-scripted MI sessions based on the scripts developed in the pilot study.
Read Educate and Develop Youth (READY) Comparison
BehavioralThe comparison group will receive an attention contact control intervention about school readiness promotion adapted from R.E.A.D.Y. (Read Educate and Develop Youth) designed by the Michigan Department of Education. The intervention consists of three home-based visits, followed by phone calls during the last three months of the intervention. For each visit and phone call, participants will receive tailored print materials, and during the 6 months of the interventions, they will receive text messages 2x/week. The intervention will be delivered in English or Spanish by a bilingual Community Health Worker (CHW). Families will receive the same intervention components as the intervention, but about reading instead of nutrition.
Treatment groups
257 Participants
are divided into 2 treatment groupsGroup A: Home-Based Video and Motivational Interviewing InterventionExperimental treatment 1 intervention
Group B: Read Educate and Develop Youth (READY) ComparisonActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Child Diet Quality
Caloric and macronutrient intake will be averaged over two dietary recalls. Caloric and macronutrient intake will be averaged over the two recalls. Healthy Eating Index (HEI)-2015 components (total fruit, whole fruit, total vegetable, dark green and orange vegetables and legumes, total grain, whole grain, milk, meat and beans, saturated fat, sodium, added sugars, and solid fats) are assessed per 1000 kcal to provide a density-based score except for saturated fats and added sugars with are % of energy. Component scores are then summed to provide a total HEI score.
Time frame
2-24-Hour Recalls at Baseline and 2-24-Hour Recalls at 6-Month follow-up2
Child's Dermal Carotenoids
The Veggie Meter device will provide an objective, non-invasive and quick measure reflecting fruit and vegetable intake. This device uses reflection spectroscopy to detect the level of carotenoids in human skin. Three measures (10 seconds each spaced by 30-seconds) will be taken and averaged. Scores range from 0 to 800 with higher scores indicating greater fruit and vegetable intake.
Time frame
Baseline, 6-Month Follow-upSecondary outcomes
1
Food Parenting Practices
Food parenting practices will be measured by the Food Parenting Inventory. Investigators will measure pre-post changes to 8 subscales: 1) child involvement in food preparation; 2) responsiveness to child's fullness cues; 3) encourage exploration of new foods; 4) repeated presentation of new foods; 5) regular timing of meals and snacks; 6) encourage try new foods; 7) inconsistent mealtimes; 8) food as a reward; and the Healthy Eating Guidance subscale of the Comprehensive Feeding Practices Questionnaire. All of the items are rated on a 5-point Likert scale ranging from never-always and disagree-agree. Higher subscale scores indicate greater use of that practice.
Time frame
Baseline, 6-Month Follow-up2
Availability of Healthy Foods in the Home
The Home Food Inventory (HFI) will be used to assess a range of available foods in the home environment. Research staff will inventory the foods in the kitchen. The HFI includes 13 food categories (e.g., cheese, milk/dairy, F\&V), whether F\&V were fresh, canned/jarred, frozen, or dried, and two categories on food accessibility. HFI items are listed in a checklist format with yes/no options.
Time frame
Baseline, 6-Month Follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Brown University
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov