Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04802291 |
| Other study ID # |
Pro2020001192 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 15, 2023 |
| Est. completion date |
April 2025 |
Study information
| Verified date |
April 2024 |
| Source |
Rutgers, The State University of New Jersey |
| Contact |
Carol Byrd-Bredbenner, PhD |
| Phone |
8489320965 |
| Email |
bredbenner[@]sebs.rutgers.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Parents are children's primary role models, are food and physical activity gatekeepers, and
create the structure/lifestyle environment within the home. Thus, parents strongly influence
children's weight-related behaviors and have the opportunity to cultivate a "culture of
health" within the home. Yet, there continues to be a dearth of evidence-based obesity
prevention intervention programs, especially for families with children aged 6 to 11 years,
commonly called the middle childhood years. The aim of the HomeStyles-2 online learning mode
RCT is to determine whether this novel, age-appropriate, family intervention enables and
motivates parents to shape their home environments and weight-related lifestyle practices
(i.e., diet, exercise, sleep) to be more supportive of optimal health and reduced risk of
obesity in their middle childhood youth more than those in the control condition. The RCT
will include the experimental group and an attention control group who will engage in a bona
fide concurrent treatment different in subject matter but equal in nonspecific treatment
effects. The participants will be families with school-age children who are systematically
randomly assigned by computer to study condition. The HomeStyles intervention is predicated
on the social cognitive theory and a social ecological framework. The RCT will collect
sociodemographic characteristics of the participant, child, and partner/spouse; child and
parent health status; parent weight-related cognitions; weight-related behaviors of the
parent and child; and weight-related characteristics of the home environment. Enrollment for
this study will begin mid-2021.This paper describes these aspects of the HomeStyles-2
intervention: rationale; sample eligibility criteria and recruitment; study design;
experimental group intervention theoretical and philosophical underpinnings, structure,
content, and development process; attention control intervention; survey instrument
development and components; outcome measures; and planned analyses.
Description:
The aim of the HomeStyles-2 online learning mode RCT is to determine whether this novel,
age-appropriate, family intervention enables and motivates parents to shape their home
environments and weight-related lifestyle practices (i.e., diet, exercise, sleep) to be more
supportive of optimal health and reduced risk of obesity in their middle childhood youth more
than those in the control condition. RCT Design CONSORT guidelines extension for social and
psychological intervention trials will be used to generate a participant flow diagram and
report RCT enrollment and retention data.113 Interested participants will begin by completing
a short eligibility screener survey. Eligible participants who give informed consent will
have immediate access to the baseline survey. Those who complete the baseline survey, meet
survey plausibility checks (e.g., consistent answers to items measuring the same concept,
meet minimal likely completion time, do not answer to all questions on a survey page the
same), and complete the registration page (i.e., provide name and contact information) will
be enrolled in the RCT. Enrolled participants will be systematically randomized by computer
by alternating assignment to the experimental or attention control study condition.
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
receive intervention materials starting immediately after registration and at weekly
intervals for 8 weeks. In week 9 of the study, participants will be invited to take the post
survey to assess intervention effects Approximately 8 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.
Each week parents will be encouraged to spend about 15 minutes reviewing intervention
materials; think about the changes like those suggested in the materials that could help
their families; and implement 1 or 2 easy, quick, low-cost changes in their homes.
Intervention materials (described in a subsequent section) provided each week for 8 weeks
include an electronic informational guide for parents, tracker to list guide-related goals
for the week and monitor progress toward them, 3 to 4 encouraging nudges delivered by SMS and
email, and a guide for kids that is available electronically and is mailed to the participant
homes along with a reminder magnet.
Participant progress through the RCT will be monitored by project staff by observing their
visits to the website. Bilingual staff will be trained in customer service strategies and
instructed to quickly address any participant queries submitted by email or phone using
scripted responses to ensure equitable care across study groups. Participants will receive
modest stipends that increase in value after they complete each survey.
Experimental Group Intervention 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). Like HomeStyles for preschoolers, 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. A
positive approach teaches individuals what they can do (eat more fruits) rather than giving
prohibitions (cut out fries). Substantial evidence supports parent preference for positive
messages and the value of promoting positive vs restrictive behaviors to achieve health
goals.
Intervention Content. 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 most salient factors affecting school-age
children's health and nutritional status that emerged were inadequate intake of fruits and
vegetables, infrequent family meals, excessive consumption of sugar-sweetened beverages,
large portion sizes, irregular breakfast consumption, limited physical activity, and
inadequate sleep. An additional factor was children's limited food preparation skills.
Attitudes toward engaging in healthy behaviors (i.e., eating fruits and vegetables, having
family meals, curtailing intake of sweet beverages, controlling portion sizes, eating
breakfast, getting physical exercise and limiting screentime, getting sufficient sleep, and
giving children food preparation opportunities), barriers to performing healthy behaviors,
strategies for overcoming barriers to healthy behaviors, and confidence in the ability to
perform healthy behaviors regularly, as well as determinants of quality of life, were
explored via focus groups with parents of middle-childhood youth and children ages 6 to 11
years.
Attention Control Intervention The attention control intervention will use bona fide,
credible materials that are structurally equivalent to the experimental group. The attention
control treatment will be credible in that it focuses on a topic fitting the description of
the study recruitment materials (i.e., shaping homes and lifestyles to help kids grow up even
happier and healthier) yet providing distinctly different, non-overlapping content (i.e.,
home safety) devoid of the RCT "active" ingredient (i.e., content related to childhood
obesity prevention). The attention control intervention materials include the same components
as those used in the experimental group (i.e., parent guides, trackers, children's guides,
and reminder magnets) with the content focused on home safety.
The Safe HomeStyles parent guides, like the HomeStyles! Guide for the experimental group
provided an overview of home safety. The other parent guides, as well as the children's
guides, trackers, and reminder magnets, focus on indoor air quality, mold & moisture,
hazardous household products, carbon monoxide, home safety, foodborne illness, and
refrigerator temperatures. The Safe HomeStyles materials have an appearance and structure
similar to those in the experimental group.
Instruments 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. Online survey collection procedures will
be used to collect baseline, post, and follow-up data. The survey will collect
sociodemographic characteristics of the participant, child, and partner/spouse; child and
parent health status; parent weight-related cognitions; weight-related behaviors of the
parent and child; and weight-related characteristics of the home environment.
