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

Indiana University

Status: Completed

Conditions: Childhood Obesity

Treatments: Behavioral: Newsletters; Behavioral: Family-based Telehealth Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04720703

2002454944

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 41 patients

Sex: All

Ages: 5 to 11 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

41 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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.

Treatment:

Behavioral: Family-based Telehealth Intervention

Wait-list Control Group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Newsletters