A Theory Driven, Rurally Tailored, Family-Based, Telehealth Intervention for Childhood Obesity
NCT ID: NCT04720703
Last Updated: 2023-06-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
41 participants
INTERVENTIONAL
2021-08-15
2022-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention Group
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.
Family-based Telehealth Intervention
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.
Wait-list Control Group
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.
Newsletters
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).
Interventions
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Newsletters
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 Intervention
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
5 Years
11 Years
ALL
Yes
Sponsors
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Indiana University
OTHER
Responsible Party
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Wasantha P. Jayawardene
Assistant Research Scientist
Principal Investigators
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Wasantha P Jayawardene, MD, MS, PhD
Role: PRINCIPAL_INVESTIGATOR
Indiana University School of Public Health-Bloomington
Mary Lynn Davis-Ajami, PhD, MBA, MS
Role: PRINCIPAL_INVESTIGATOR
Indiana University School of Nursing-Bloomington
Allisandra G Kummer
Role: STUDY_DIRECTOR
Indiana University School of Public Health-Bloomington
Myat Su
Role: STUDY_DIRECTOR
Indiana University School of Public Health Bloomington
Locations
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Clinical and Translational Sciences Institute (CTSI)
Indianapolis, Indiana, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2002454944
Identifier Type: -
Identifier Source: org_study_id
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