Home-Based Nutrition Program for Healthy Eating

Recruiting in Palo Alto (17 mi)

Overseen by Alison Tovar, PhD MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Brown University

Disqualifiers: Underweight, Feeding disorder, Dietary restriction

No Placebo Group

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Home-Based Video and Motivational Interviewing Intervention for healthy eating?

Research shows that motivational interviewing (MI), a key part of this treatment, helps families set and achieve healthy eating goals, improves diet quality, and enhances the home food environment. Studies have found that MI can stabilize or slow down weight gain in children and improve health behaviors in parents, which can positively affect their children's diets. ^{1 2 3 4 5}

Is the Home-Based Nutrition Program for Healthy Eating safe for participants?

The studies on similar programs, like Strong Families Start at Home and HOME Plus, show that these interventions are generally well-accepted and safe for families, focusing on improving diet quality and family meal practices without reported safety concerns. ^{1 5 6 7 8}

How is the Home-Based Video and Motivational Interviewing Intervention different from other treatments for promoting healthy eating?

This treatment is unique because it combines home-based video sessions with motivational interviewing (a technique to encourage behavior change) to improve family nutrition, focusing on low-income, predominantly Hispanic/Latinx families. Unlike other interventions that may occur in group settings, this program is delivered directly in the home, making it more accessible and personalized for families. ^{1 6 8 9 10}

Research Team

Alison Tovar, PhD MPH

Principal Investigator

Brown University

Eligibility Criteria

This trial is for Latinx/Hispanic primary caregivers, at least 18 years old, who have a child aged 2-5. They must live with the child most of the time, share at least three evening meals per week with them, and be willing to record one meal. Participants need a smartphone but shouldn't have been in the R34 study.

Inclusion Criteria

Self-identity as Latinx/Hispanic

Eat a minimum of three evening meals per week with the child

Not have participated in the R34 study

Exclusion Criteria

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 Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a home-based parental nutrition intervention including home visits, phone calls, and text messages to improve diet quality

6 months

3 home visits, 3 phone calls, bi-weekly text messages

Follow-up

Participants are monitored for changes in diet quality and food parenting practices

6 months

Follow-up assessments at 6 and 12 months

Treatment Details

Interventions

• Home-Based Video and Motivational Interviewing Intervention (Behavioral Intervention)

Trial Overview The trial tests if a home-based nutrition program can improve children's diets. It involves monthly home visits and calls from a support coach over three months, plus educational materials and texts for six months. The effectiveness will be compared to a control group receiving different materials.

Participant Groups

Group I: Home-Based Video and Motivational Interviewing Intervention Experimental Treatment 1 Intervention

The intervention will be delivered in English or Spanish by a trained CHW and consists of three home-based visits with tailored print materials, text-messages delivered 2x/week, followed by monthly tailored print materials and phone calls during the last three months of the intervention. For in-home visits, the CHW will deliver a Motivational Interviewing session based on scripts developed in the R34. For phone calls, parents will receive a 30-minute Motivational Interviewing phone call to check in on goals and barriers and reinforce earlier concepts. For text messages, parents will be sent two times/week messages related to objectives targeted during that month's visit, such as parents setting good examples and giving children autonomy in eating. For print materials, parents will receive printed materials, highlighting nutrition and parental feeding guidance.

Group II: Read Educate and Develop Youth (READY) Comparison Active Control 1 Intervention

As done in the R34, the 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 (Refs). Families in the comparison arm will receive the same intervention components as the intervention arm, but these will be focused on child reading rather than nutrition. Parents will send a video of themselves reading with a child, receive 3 home visits and 48 text-messages as well as newsletters for each visit. Instead of receiving cooking materials during the second home visit, they will receive books to read with their children.

Who Is Running the Clinical Trial?

Brown University

Lead Sponsor

Trials

480

Recruited

724,000+

Mukesh Jain

Brown University

Chief Medical Officer since 2022

MD from Harvard Medical School

Christina H. Paxson

Brown University

Chief Executive Officer since 2012

PhD in Economics from Columbia University

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Dr. Diana W. Bianchi

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Chief Executive Officer since 2016

MD from Stanford University

Dr. Alison Cernich

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Chief Medical Officer since 2020

PhD in Clinical Psychology from University of Maryland

Findings from Research

The HOME Plus intervention, which included 81 families and 10 group sessions, effectively promoted healthful eating and increased family meal frequency, showing significant behavior changes in participants.

Motivational interviewing (MI) was well-received, with an 87% completion rate for goal-setting calls, and over 85% of families reported achieving their goals, indicating MI's effectiveness in supporting behavior change in childhood obesity prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Example of How to Supplement Goal Setting to Promote Behavior Change for Families Using Motivational Interviewing. Draxten, M., Flattum, C., Fulkerson, J.[2018]

A training program on motivational interviewing significantly improved WIC counselors' knowledge of effective obesity prevention strategies, with knowledge retention observed three months post-training.

Despite the increased knowledge, there was no improvement in the quality of documented behavior change goals in client charts, indicating that further support and time are necessary for counselors to effectively apply these strategies in practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Impact of Training in Obesity Prevention Methods on the Counseling, Knowledge, and Skills of WIC Nutritionists in Georgia, 2014-2015. Palmer, W., Henderson, D., Stahnke, B., et al.[2018]

Preschoolers participating in the family-based obesity intervention (LAUNCH) showed a significant improvement in diet quality, as measured by the Healthy Eating Index-2010, compared to those in motivational interviewing (MI) and standard care (STC) conditions.

The LAUNCH intervention also led to a reduction in the number of 'red' foods (high in fat and sugar) available in the home environment, indicating a positive change in dietary habits and food availability for families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in diet quality and home food environment in preschool children following weight management. Robson, SM., Ziegler, ML., McCullough, MB., et al.[2020]

The study involving 36 parent and adult caregiver-child dyads showed that motivational interviewing (MI) by registered dietitians can lead to improvements in the dietary quality of caregivers, as indicated by increased Healthy Eating Index (HEI) scores.

Improvements in the home food environment were also observed, suggesting that MI not only benefits the caregivers' diets but may also positively influence children's dietary habits and the overall home setting for healthier eating.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Support for the Use of Motivational Interviewing to Improve Parent/Adult Caregiver Behavior for Obesity and Cancer Prevention. Braun, A., Portner, J., Xu, M., et al.[2023]

The HOME Plus intervention, which included 81 families with children aged 8-12, successfully promoted healthy eating and increased family meal participation through ten monthly sessions and motivational calls, achieving a high average attendance of 68%.

Families reported high satisfaction with the program, particularly enjoying cooking together and learning new healthy recipes, indicating that community-based interventions can effectively engage families in improving dietary quality and preventing obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HOME Plus: Program design and implementation of a family-focused, community-based intervention to promote the frequency and healthfulness of family meals, reduce children's sedentary behavior, and prevent obesity. Flattum, C., Draxten, M., Horning, M., et al.[2018]

The Strong Families Start at Home pilot trial demonstrated feasibility and high acceptability, with 63% of participating families retained over 6 months, despite challenges posed by COVID-19.

The intervention led to significant improvements in healthy eating behaviors, including increased consumption of whole fruits and reduced sodium intake, along with enhanced food parenting practices such as regular meal timing and minimizing distractions during meals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results from the Strong Families Start at Home/Familias Fuertes Comienzan en Casa: feasibility randomised control trial to improve the diet quality of low-income, predominantly Hispanic/Latinx children. Tovar, A., Fox, K., Gans, KM., et al.[2023]

A pilot study involving 104 low-income parents showed that a home-based cooking intervention significantly increased their confidence in preparing vegetables and encouraged them to try a variety of vegetables, with 96% participation in activities.

Most home visitors found the cooking intervention acceptable and feasible, suggesting that home visiting programs could effectively improve vegetable consumption attitudes and behaviors among families, although further research is needed to evaluate actual changes in vegetable intake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Cooking Intervention to Increase Vegetable Consumption by Parents With Children Enrolled in an Early Head Start Home Visiting Program: A Pilot Study in Portland, Oregon, 2013-2014. Izumi, BT., Eckhardt, CL., Wilson, DP., et al.[2019]

Community-based cooking skill interventions significantly boost adults' confidence in their cooking abilities, regardless of age or setting.

While these programs show some positive effects on increasing fruit and vegetable intake, the evidence is inconsistent, highlighting the need for better study designs and long-term evaluations to fully understand their impact on dietary habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community Interventions to Improve Cooking Skills and Their Effects on Confidence and Eating Behaviour. Garcia, AL., Reardon, R., McDonald, M., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

An Example of How to Supplement Goal Setting to Promote Behavior Change for Families Using Motivational Interviewing. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of a community-based obesity intervention utilizing motivational interviewing and community resource mobilization for low-income families: Study protocol and baseline characteristics. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Evaluating the Impact of Training in Obesity Prevention Methods on the Counseling, Knowledge, and Skills of WIC Nutritionists in Georgia, 2014-2015. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Changes in diet quality and home food environment in preschool children following weight management. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Preliminary Support for the Use of Motivational Interviewing to Improve Parent/Adult Caregiver Behavior for Obesity and Cancer Prevention. [2023]

6. England pubmed.ncbi.nlm.nih.gov

HOME Plus: Program design and implementation of a family-focused, community-based intervention to promote the frequency and healthfulness of family meals, reduce children's sedentary behavior, and prevent obesity. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

The RD parent empowerment program creates measurable change in the behaviors of low-income families and children: an intervention description and evaluation. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Results from the Strong Families Start at Home/Familias Fuertes Comienzan en Casa: feasibility randomised control trial to improve the diet quality of low-income, predominantly Hispanic/Latinx children. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

A Cooking Intervention to Increase Vegetable Consumption by Parents With Children Enrolled in an Early Head Start Home Visiting Program: A Pilot Study in Portland, Oregon, 2013-2014. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Community Interventions to Improve Cooking Skills and Their Effects on Confidence and Eating Behaviour. [2022]