CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 41 enrolled
Drug / intervention
Newsletters +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04720703
NCT04720703N/ACompleted

A Theory Driven, Rurally Tailored, Family-Based, Telehealth Intervention for Childhood Obesity: A Randomized Waitlist Controlled Trial

Indiana University·interventional·Posted Jan 22, 2021·Updated Jun 2, 2023

In Brief

A clinical study evaluating Newsletters and Family-based Telehealth Intervention for Childhood Obesity. Completed, enrolled 41 participants across 1 site.

Detailed Summary

This pilot trial aims to improve the lives of individuals in rural Indiana by addressing the leading cause of death, obesity. The purpose is to help children and their families develop healthy behaviors to decrease childhood obesity. The short-term goal of this study to develop a prototype of theory-driven, tailored, family-based, telehealth intervention that can sustainably reduce pediatric obesity rates in rural areas. The long-term goal of this study is to sustainably reduce the rates of pediatric obesity and its consequences in rural areas, via behavioral change. It is hypothesized that after participating in this intervention, children will show improvement in age-based body mass index percentile and improved behavioral indicators related to nutrition, physical activity, sleep, and sedentary behaviors. Additionally, it is hypothesized that parents will show improved attitudes and skills for managing their child's behavior and improved perceived stress and perceived quality of life. Finally, levels of attendance, participation, and technology feasibility will indicate a successful intervention.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJan 22, 2021
Enrollment StartAug 15, 2021
Primary CompletionMar 31, 2022
Study CompletionJun 30, 2022
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 5.4 years ago

Interventions

Newslettersbehavioral

Similar to prior empirical pediatric obesity interventions (Elder et al., 2009), the active attention waitlist control group will receive monthly newsletters that focus on physical activity, healthy eating, and screen time. These newsletters will be based on standard materials from the We Can program of the National Heart, Lung, and Blood Institute (NHLBI).

Family-based Telehealth Interventionbehavioral

All communications related to the intervention will occur through weekly small group video conferencing calls via Zoom and emails or text messages. The intervention will include diverse topics proven effective in prior interventions (Davis et al., 2019; McLean et al., 2003), including reading food labels, eating out, eating at social gatherings, sticker charts, praising/rewarding healthy choices, healthy foods available at home, portion sizes, healthy/easy/low-cost cooking ideas, goal setting, monitoring screen time, exercise opportunities available in neighborhood, family exercise ideas, and healthy sleep. The research team will also send relevant video/audio clips, brochures, reminders (text messages and emails) every week.