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

NCT04720703 | Completed

• 1 other identifier: 2002454944
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Childhood Obesity

Keywords

childhood obesity; telehealth; family-based

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Change in Children's Physical Activity, Sleep Behavior, and Nutrition

  Change from baseline BMI at 12 weeks

• Change in Children's Physical Activity, Sleep Behavior, and Nutrition

  Change from 12 week BMI at 26 weeks

• Change in Parents' Perceived Stress and Perceived Quality of Life

  Change from baseline BMI at 12 weeks

• Change in Parents' Perceived Stress and Perceived Quality of Life

  Change from 12 week BMI at 26 weeks

Other Outcomes (4)

• Change in Children's Body Mass Index

  Change from baseline BMI at 12 weeks

• Change in Children's Body Mass Index

  Change from 12 week BMI at 26 weeks

• Change in Parents' Self-Reported Beliefs, Behaviors, and Attitudes

  Change from baseline BMI at 12 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Wait-list Control Group

ACTIVE COMPARATOR

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

Interventions

Newsletters BEHAVIORAL

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).

Wait-list Control Group

Family-based Telehealth Intervention BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

• Age: 5 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Clinical and Translational Sciences Institute (CTSI)

Indianapolis, Indiana, 46202, United States

Location

Related Publications (14)

• Andrews KR, Silk KS, Eneli IU. Parents as health promoters: a theory of planned behavior perspective on the prevention of childhood obesity. J Health Commun. 2010 Jan;15(1):95-107. doi: 10.1080/10810730903460567.

  PMID: 20390979 BACKGROUND

• Ayala GX, Elder JP. Qualitative methods to ensure acceptability of behavioral and social interventions to the target population. J Public Health Dent. 2011 Winter;71 Suppl 1(0 1):S69-79. doi: 10.1111/j.1752-7325.2011.00241.x.

  PMID: 21656958 BACKGROUND

• Choi L, Liu Z, Matthews CE, Buchowski MS. Validation of accelerometer wear and nonwear time classification algorithm. Med Sci Sports Exerc. 2011 Feb;43(2):357-64. doi: 10.1249/MSS.0b013e3181ed61a3.

  PMID: 20581716 BACKGROUND

• Davis AM, Beaver G, Dreyer Gillette M, Nelson EL, Fleming K, Swinburne Romine R, Sullivan DK, Lee R, Pettee Gabriel K, Dean K, Murray M, Faith M. iAmHealthy: Rationale, design and application of a family-based mHealth pediatric obesity intervention for rural children. Contemp Clin Trials. 2019 Mar;78:20-26. doi: 10.1016/j.cct.2019.01.001. Epub 2019 Jan 7.

  PMID: 30630108 BACKGROUND

• Davis AM, Boles RE, James RL, Sullivan DK, Donnelly JE, Swirczynski DL, Goetz J. Health behaviors and weight status among urban and rural children. Rural Remote Health. 2008 Apr-Jun;8(2):810. Epub 2008 Apr 15.

  PMID: 18426334 BACKGROUND

• Davis AM, James RL, Boles RE, Goetz JR, Belmont J, Malone B. The use of TeleMedicine in the treatment of paediatric obesity: feasibility and acceptability. Matern Child Nutr. 2011 Jan;7(1):71-9. doi: 10.1111/j.1740-8709.2010.00248.x.

  PMID: 21108739 BACKGROUND

• Epstein LH, Paluch RA, Roemmich JN, Beecher MD. Family-based obesity treatment, then and now: twenty-five years of pediatric obesity treatment. Health Psychol. 2007 Jul;26(4):381-91. doi: 10.1037/0278-6133.26.4.381.

  PMID: 17605557 BACKGROUND

• Gallagher KS, Davis AM, Malone B, Landrum Y, Black W. Treating rural pediatric obesity through telemedicine: baseline data from a randomized controlled trial. J Pediatr Psychol. 2011 Jul;36(6):687-95. doi: 10.1093/jpepsy/jsr011. Epub 2011 Mar 3.

  PMID: 21372069 BACKGROUND

• Hunsberger M, O'Malley J, Block T, Norris JC. Relative validation of Block Kids Food Screener for dietary assessment in children and adolescents. Matern Child Nutr. 2015 Apr;11(2):260-70. doi: 10.1111/j.1740-8709.2012.00446.x. Epub 2012 Sep 24.

  PMID: 23006452 BACKGROUND

• Marchionda DM, Slesnick N. Family therapy retention: an observation of first-session communication. J Marital Fam Ther. 2013 Jan;39(1):87-97. doi: 10.1111/j.1752-0606.2011.00279.x. Epub 2012 Feb 9.

  PMID: 25073845 BACKGROUND

• McLean N, Griffin S, Toney K, Hardeman W. Family involvement in weight control, weight maintenance and weight-loss interventions: a systematic review of randomised trials. Int J Obes Relat Metab Disord. 2003 Sep;27(9):987-1005. doi: 10.1038/sj.ijo.0802383.

  PMID: 12917703 BACKGROUND

• Romanzini M, Petroski EL, Ohara D, Dourado AC, Reichert FF. Calibration of ActiGraph GT3X, Actical and RT3 accelerometers in adolescents. Eur J Sport Sci. 2014;14(1):91-9. doi: 10.1080/17461391.2012.732614. Epub 2012 Oct 18.

  PMID: 24533499 BACKGROUND

• Elder JP, Ayala GX, Slymen DJ, Arredondo EM, Campbell NR. Evaluating psychosocial and behavioral mechanisms of change in a tailored communication intervention. Health Educ Behav. 2009 Apr;36(2):366-80. doi: 10.1177/1090198107308373. Epub 2007 Dec 12.

  PMID: 18077657 BACKGROUND

• Morgan DG, Kosteniuk J, Stewart N, O'Connell ME, Karunanayake C, Beever R. The telehealth satisfaction scale: reliability, validity, and satisfaction with telehealth in a rural memory clinic population. Telemed J E Health. 2014 Nov;20(11):997-1003. doi: 10.1089/tmj.2014.0002. Epub 2014 Oct 1.

  PMID: 25272141 BACKGROUND

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Wasantha P Jayawardene, MD, MS, PhD

  Indiana University School of Public Health-Bloomington

  PRINCIPAL INVESTIGATOR

• Mary Lynn Davis-Ajami, PhD, MBA, MS

  Indiana University School of Nursing-Bloomington

  PRINCIPAL INVESTIGATOR

• Allisandra G Kummer

  Indiana University School of Public Health-Bloomington

  STUDY DIRECTOR

• Myat Su

  Indiana University School of Public Health Bloomington

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Research Scientist

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 22, 2021
• Study Start: August 15, 2021
• Primary Completion: March 31, 2022
• Study Completion: June 30, 2022
• Last Updated: June 2, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: IPD will be available beginning 6 months and ending 5 years following the date of our article publication.
• Access Criteria: IPD will be available to researchers who provide a methodologically sound proposal with the objective to achieve aims in the approved proposal. Proposals should be directed to wajayawa@indian.edu To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (Link to be included).

Locations

US (1)