Melissa A Napolitano1, Jessica A Whiteley2, Meghan N Mavredes3, Jamie Faro4, Loretta DiPietro5, Laura L Hayman6, Charles J Neighbors7, Samuel Simmens8. 1. Department of Prevention and Community Health, The George Washington University, Milken Institute School of Public Health, 950 New Hampshire Ave NW, Suite 300, Washington, DC 20052, USA; Department of Exercise and Nutrition Sciences, The George Washington University, Milken Institute School of Public Health, 950 New Hampshire Ave NW, Suite 200, Washington, DC 20052, USA. Electronic address: mnapolitano@gwu.edu. 2. College of Nursing and Health Sciences, University of Massachusetts Boston, Exercise and Health Sciences Program, 100 Morrissey Blvd, Science Center, 2(nd) Floor, Boston, MA 02125-3393, USA. Electronic address: Jessica.Whiteley@umb.edu. 3. Department of Prevention and Community Health, The George Washington University, Milken Institute School of Public Health, 950 New Hampshire Ave NW, Suite 300, Washington, DC 20052, USA. Electronic address: mmavredes@gwu.edu. 4. College of Nursing and Health Sciences, University of Massachusetts Boston, Exercise and Health Sciences Program, 100 Morrissey Blvd, Science Center, 2(nd) Floor, Boston, MA 02125-3393, USA. Electronic address: Jamie.Faro001@umb.edu. 5. Department of Exercise and Nutrition Sciences, The George Washington University, Milken Institute School of Public Health, 950 New Hampshire Ave NW, Suite 200, Washington, DC 20052, USA. Electronic address: ldp1@gwu.edu. 6. University of Massachusetts Boston, Department of Nursing, 100 Morrissey Blvd, Quinn Administration-01-01, Boston, MA 02125-3393, USA. Electronic address: Laura.Hayman@umb.edu. 7. Columbia University, The National Center on Addiction and Substance Abuse, Health Services Research, 633 Third Avenue, 19th Floor, New York, NY 10017, USA. Electronic address: CNeighbors@casacolumbia.org. 8. The George Washington University, Milken Institute School of Public Health, Department of Epidemiology and Biostatistics, Science & Engineering Hall, 800 22nd St NW, Floor 7, Washington, DC 20052, USA. Electronic address: simmens@gwu.edu.
Abstract
BACKGROUND: The transitional period from late adolescence to early adulthood is a vulnerable period for weight gain, with a twofold increase in overweight/obesity during this life transition. In the United States, approximately one-third of young adults have obesity and are at a high risk for weight gain. PURPOSE: To describe the design and rationale of a National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) sponsored randomized, controlled clinical trial, the Healthy Body Healthy U (HBHU) study, which compares the differential efficacy of three interventions on weight loss among young adults aged 18-35years. METHODS: The intervention is delivered via Facebook and SMS Text Messaging (text messaging) and includes: 1) targeted content (Targeted); 2) tailored or personalized feedback (Tailored); or 3) contact control (Control). Recruitment is on-going at two campus sites, with the intervention delivery conducted by the parent site. A total of 450 students will be randomly-assigned to receive one of three programs for 18months. We hypothesize that: a) the Tailored group will lose significantly more weight at the 6, 12, 18month follow-ups compared with the Targeted group; and that b) both the Tailored and Targeted groups will have greater weight loss at the 6, 12, 18month follow-ups than the Control group. We also hypothesize that participants who achieve a 5% weight loss at 6 and 18months will have greater improvements in their cardiometabolic risk factors than those who do not achieve this target. We will examine intervention costs to inform implementation and sustainability other universities. Expected study completion date is 2019. CONCLUSIONS: This project has significant public health impact, as the successful translation could reach as many as 20 million university students each year, and change the current standard of practice for promoting weight management within university campus communities. ClinicalTrial.gov: NCT02342912.
RCT Entities:
BACKGROUND: The transitional period from late adolescence to early adulthood is a vulnerable period for weight gain, with a twofold increase in overweight/obesity during this life transition. In the United States, approximately one-third of young adults have obesity and are at a high risk for weight gain. PURPOSE: To describe the design and rationale of a National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) sponsored randomized, controlled clinical trial, the Healthy Body Healthy U (HBHU) study, which compares the differential efficacy of three interventions on weight loss among young adults aged 18-35years. METHODS: The intervention is delivered via Facebook and SMS Text Messaging (text messaging) and includes: 1) targeted content (Targeted); 2) tailored or personalized feedback (Tailored); or 3) contact control (Control). Recruitment is on-going at two campus sites, with the intervention delivery conducted by the parent site. A total of 450 students will be randomly-assigned to receive one of three programs for 18months. We hypothesize that: a) the Tailored group will lose significantly more weight at the 6, 12, 18month follow-ups compared with the Targeted group; and that b) both the Tailored and Targeted groups will have greater weight loss at the 6, 12, 18month follow-ups than the Control group. We also hypothesize that participants who achieve a 5% weight loss at 6 and 18months will have greater improvements in their cardiometabolic risk factors than those who do not achieve this target. We will examine intervention costs to inform implementation and sustainability other universities. Expected study completion date is 2019. CONCLUSIONS: This project has significant public health impact, as the successful translation could reach as many as 20 million university students each year, and change the current standard of practice for promoting weight management within university campus communities. ClinicalTrial.gov: NCT02342912.
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