Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05019339 |
| Other study ID # |
IRB201700192 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 19, 2021 |
| Est. completion date |
April 30, 2023 |
Study information
| Verified date |
May 2023 |
| Source |
University of Florida |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Childhood obesity prevention efforts are needed in the United States, especially for families
with low income. Educating parents and caregivers on simple lifestyle and affordable home
environment changes is an effective strategy to improve health outcomes for the entire
family. Therefore, the purpose of this study is to determine whether HomeStyles-2, a
nutrition education and childhood obesity prevention program for families with children in
middle childhood (ages 6 to 11 years), motivates parents to shape their home environments and
weight-related lifestyle practices to be more supportive of optimal health and weight status
of their children aged 6-11 years more so than those in the control condition. The study will
include the experimental group and an attention control group who will engage in a nutrition
education program, Eat Healthy Be Active, that is equal in nonspecific treatment effects but
does not overlap on topics covered in HomeStyles-2. This study will be implemented in
Florida's Supplemental Nutrition Assistance Program-Education (SNAP-Ed) program, which
provides nutrition education and obesity prevention supports for individuals with low income
who are receiving or eligible for SNAP benefits. Nutrition Educators will be randomized to
the experimental or attention control condition, and will lead participants through virtual,
group-based nutrition education series. The following data will be collected:
sociodemographic characteristics of the participant and child; child and parent health
status; parent weight-related cognitions; weight-related behaviors of the participant and
child; and weight-related characteristics of the home environment. Enrollment for this study
will begin late-2021.
Description:
The aim of the HomeStyles-2 for SNAP-Ed families RCT is to determine whether HomeStyles-2
enables and motivates SNAP-Ed parents and child caregivers (e.g., guardians) to shape their
home environments and weight-related lifestyle practices to be more supportive of optimal
health and weight status of their children aged 6-11 years than those in the control
condition. The study will be a two-arm, cluster randomized trial and will follow the CONSORT
guidelines extension for cluster trials. Individual counties or groups of small counties
operate as a single division with one individual who supervises the SNAP-Ed Nutrition
Educators assigned to that division. Every participating division will function as a cluster
in the study. Half of the Nutrition Educators in each cluster that choose to participate in
the study will be randomized and trained to only deliver the experimental treatment and the
other half the control intervention. Eligible participants will be recruited by Nutrition
Educators through existing SNAP-Ed community partnerships.
Once identified, eligible individuals will be screened for eligibility, consented, and
complete the baseline survey with a trained research assistant over the phone. Participants
who complete the baseline survey and meet survey plausibility checks will be enrolled in the
study. Their assignment to experimental or attention control condition is dependent upon the
Nutrition Educator's random assignment to teach experimental or attention control curriculum.
Recruitment materials and the bona fide treatment to be delivered to the attention control
group are designed to blind participant assignment to study condition.
Participants will complete a six-week virtual nutrition education program, with each weekly
session lasting approximately 30 minutes. Nutrition Educators will conduct the sessions over
video conferencing software (e.g., Zoom). Participants will receive intervention materials by
mail before the first class of the series and will have electronic access to the materials
through a free learning management system. After the six-week virtual nutrition education
program, participants will be invited to take the post survey over the telephone with a
trained research assistant. Approximately 4 to 10 weeks after participants complete the post
survey, they will be invited to take the follow-up survey to assess longer-term intervention
effects.
Participant progress through the RCT will be monitored by tracking attendance at each
educational session. Trained research assistants and SNAP-Ed staff will be available to
answer questions throughout the study. Participants will receive modest stipends that
increase in value after they complete each survey.
The HomeStyles-2 experimental group intervention materials (i.e., "Healthy" HomeStyles-2)
were designed to be congruent with White House and IOM recommendations for home-centered
obesity prevention interventions and critical elements for effective interventions (e.g.,
interventions are positive, culturally sensitive, supportive of parent-child interaction and
child development; develop realistic, effective plans that empower families). HomeStyles-2
for middle childhood intervention materials provide intensive, interactive, fun,
non-judgmental opportunities for parents to shape their home environments and lifestyle
practices to protect child health. They also promote positive strategies and changes that
adults can control in their environments to reduce risk of excessive weight gain in their
middle childhood youth. Key factors contributing to childhood obesity that can be suitably
addressed in the home environment with middle childhood kids identified for inclusion in the
intervention materials were selected using systematic literature reviews and input from
experts in childhood obesity prevention. The topics that emerged and will be covered in the
SNAP-Ed arm of the study include inadequate intake of fruits and vegetables, infrequent
family meals, excessive consumption of sugar-sweetened beverages, large portion sizes, and
irregular breakfast consumption. An additional factor was children's limited food preparation
skills.
The attention control group will receive a different but bona fide, credible treatment at the
same time as the experimental group. The control condition will provide information distinct
from the "active" ingredient in the experimental intervention, while still aligning with the
description of the study recruitment materials (i.e., to build happier, healthier families)
and adhering to the regulations governing educational content of SNAP-Ed programming. The
control condition materials are from the SNAP-Ed Eat Healthy, Be Active program and were
adapted to match the experimental intervention in number of sessions, length of sessions,
4-page informational guide, goal-setting activity, and incentive items.
To adapt the experimental and control programs for virtual delivery, a Microsoft PowerPoint
presentation and script was created for each of the educational sessions. The scripts include
suggested questions and opportunities for Nutrition Educators to use to actively engage
participants in the session, such as by speaking, typing questions and comments in the chat
box, or using emojis to register reactions.
The study survey, "Home Obesogenicity Measure of EnvironmentS"-Families with School-age Kids
(HOMES-FSAK), will be used to collect baseline, post, and follow-up data in the HomeStyles-2
RCT. The Social Cognitive Theory along with the key concepts addressed in the HomeStyles-2
guides provided the framework for identification of cognitions, behaviors, and aspects of the
home environment to be assessed. The survey will collect sociodemographic characteristics of
the participant and child; child and participant health status; parent weight-related
cognitions; weight-related behaviors of the parent and child; and weight-related
characteristics of the home environment.
