A Theory Driven, Rurally Tailored, Family-Based, Telehealth Intervention for Childhood Obesity

Study Overview
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Brief Summary
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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.

Detailed Description
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This study will utilize a purposive (non-random) sampling strategy. Children belonging to a family headed by a parent/guardian will be identified local healthcare providers practicing in any rural Indiana counties. The sampling frame will be based on the list of pediatric patients who meet eligibility criteria who currently receive services from the rural pediatric practices. Members of the research team will not have access to any medical records. Identification of the universe of eligible participants is at the sole discretion of the healthcare provider. This study has a set of primary and secondary objectives for children and their parents/guardians, and a separate set of hypotheses for the feasibility of intervention delivery. The short-term goal is to develop a prototype for a theory-driven, tailored, family-based, telehealth intervention that can sustainably reduce pediatric obesity rates in rural areas. The long-term goal is to sustainably reduce pediatric obesity and its consequences in rural areas, solely via behavioral change. The primary objectives for children are to improve children's behavioral indicators in terms of nutrition, physical activity, sleep, and sedentary behaviors, measured both objectively and subjectively and sustain them over time. In the end of phase-1 (at crossover point), improvement of behavioral indicators related to nutrition, physical activity, sleep, and sedentary behaviors among children who were in the intervention group will be superior to those in the control group, however, there will be no difference after phase-2 (end of study). The secondary objective for children is to improve children's body composition, measured with the age-sex based BMI percentile. In the end of phase 1, improvement in age-sex based BMI percentile among children who were in the intervention group will be superior to those who were in the control group; however, there will be no difference after phase 2. The primary objectives for parents/guardians are to improve caregivers' attitudes and skills, measured as constructs in the Theory of Planned Behavior (i.e., attitudes toward behavior, subjective norms, perceived behavioral control, and response efficacy), that are necessary to change their child's behaviors. In the end of phase 1, parents/guardians who were in the intervention group will show improved attitudes and skills that evidence suggests helps to change their child's behaviors, compared to those who were in the control group. The secondary objectives for parents/guardians is to improve perceived stress and quality of life among parents/guardians. In the end of phase 1, perceived stress and perceived quality of life among parents/guardians will be better in the intervention group than the control group; however, there will be no difference after phase 2. The tertiary objective is to assess the feasibility of the intervention at the end of the study for the intervention group only. Intervention will have the levels of attendance and participation (i.e., interaction) and technology feasibility (i.e., internet connectivity and digital literacy) required for it to be successful.

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

Conditions
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Childhood Obesity

Intervention / Treatment
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* Behavioral: Newsletters
* Behavioral: Family-based Telehealth Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 5-11 years old Overweight (body mass index (BMI) at or over 85th percentile, but less than 95th percentile) or Obese (BMI at or over the 95th percentile) living in rural Indiana sibling of enrolled participant - must meet all inclusion criteria with the exception of BMI Exclusion Criteria: Having any of the following chronic conditions: developmental disabilities cognitive impairment eating disorders (e.g., anorexia nervosa, avoidant/restrictive food intake disorder, and eating disorders not elsewhere classified) psychiatric illnesses significant diagnosed medical problems (e.g., cancer) that limit physical activity, etc. Their only available parent parent/guardian have developmental disabilities, cognitive impairments, and psychiatric illnesses.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>The Intervention Group will receive the Family-based Telehealth Intervention for the first three months of the study period. Once they have completed the intervention, there will be a two-week washout period. After the washout period, they will receive monthly newsletters, with similar information learned in the intervention, for three months until the end of the study period. | Behavioral: Family-based Telehealth Intervention<br>* 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.<br>|
| Active Comparator: Wait-list Control Group<br>The Waitlist Control Group will receive monthly newsletters, with similar information learned in the intervention, for the first three months of the study period while the Intervention Group receives the intervention. Then, there will be a two-week washout period. After the washout period, they will receive the Family-based Telehealth Intervention for 3 months until the end of the study period. | Behavioral: Newsletters<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention Attendance | Attendance to telehealth sessions will be recorded by the interventionist and calculated as a percentage for each participant. This percentage will be calculated by dividing number of sessions attended by total number of sessions. | 26 weeks | 
| Level of Participation | Participants are asked to complete weekly tasks (e.g. updating goal sheets) and to send researchers a picture of these updating goal sheets. Level of participation will be measured by percentage of completing these weekly tasks. This percentage will be calculated by dividing number of completed tasks by total tasks. | 26 weeks | 
| Parent/Guardian Satisfaction | Parent/guardian satisfaction is measured using the Telehealth Satisfaction Scale, a 10-item questionnaire with a 4-point Likert scale taken by the parent/guardian and used to evaluate their satisfaction with the technology and the intervention. Total scores range from 10-40, and higher scores indicate higher satisfaction. | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Children's Physical Activity, Sleep Behavior, and Nutrition | Physical activity and sleep behaviors will be evaluated using objective measures from Fitbit activity trackers. A blinded assessor will obtain and evaluate the child's physical activity data by measuring their number of steps per day and per hour, number of active minutes, and distance in miles. All days with more than 8 hours of recorded activity will be evaluated. The child's sleep activity will be measured by their bedtime, wake up time, total sleep time, and restless minutes. The Fitbit assessor will evaluate all days with data for total sleep and nap times. The Block Kids Food Screener for assessing nutrient and food group consumption, created by NutritionQuest, will be used to measure nutrition. | Change from baseline BMI at 12 weeks | 
| Change in Children's Physical Activity, Sleep Behavior, and Nutrition | Physical activity and sleep behaviors will be evaluated using objective measures from Fitbit activity trackers. A blinded assessor will obtain and evaluate the child's physical activity data by measuring their number of steps per day and per hour, number of active minutes, and distance in miles. All days with more than 8 hours of recorded activity will be evaluated. The child's sleep activity will be measured by their bedtime, wake up time, total sleep time, and restless minutes. The Fitbit assessor will evaluate all days with data for total sleep and nap times. The Block Kids Food Screener for assessing nutrient and food group consumption, created by NutritionQuest, will be used to measure nutrition . | Change from 12 week BMI at 26 weeks | 
| Change in Parents' Perceived Stress and Perceived Quality of Life | Secondary outcomes for parents/guardians are perceived stress related to childcare and perceived quality of life. The short version Parent Stress Index (PSI) is a parent/guardian self-report with 36 items. The Perceived Quality of Life Scale (PQoL) has 19 items, each with an 11-point scale, plus a global item on happiness that is utilized for comparison purposes. These will be measured at baseline, post-intervention, and after the follow-up period. | Change from baseline BMI at 12 weeks | 
| Change in Parents' Perceived Stress and Perceived Quality of Life | Secondary outcomes for parents/guardians are perceived stress related to childcare and perceived quality of life. The short version Parent Stress Index (PSI) is a parent/guardian self-report with 36 items. The Perceived Quality of Life Scale (PQoL) has 19 items, each with an 11-point scale, plus a global item on happiness that is utilized for comparison purposes. These will be measured at baseline, post-intervention, and after the follow-up period. | Change from 12 week BMI at 26 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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telehealth, childhood obesity, family-based