Small Changes and Lasting Effects (SCALE) Trial: the formation of a weight loss behavioral intervention using EVOLVE.
Bottom Line: Phase II results shaped the recruitment and retention strategy for the RCT, as well as the final intervention.The RCT results are currently under analysis.The present study seeks to determine if a SC approach combined with a PA/SA intervention will result in greater weight loss at 12 months in Black and Hispanic adults compared to a SC approach alone.
Affiliation: Division of Clinical Epidemiology and Evaluative Science Research, Weill Cornell Medical College 338 East 66th Street New York, NY 10065; School of Applied Economics and Management, Cornell University 201 Warren Hall Cornell University, Ithaca, NY 14853-7801. Electronic address: email@example.com.Show MeSH
Related in: MedlinePlus
Mentions: Participants were stratified into three groups. Group I represented individuals recruited to participate in the study by themselves but asked to recommend the name of a social network member who might be interested in participating in the study as well. Group II participants had one additional eligibility criteria in that there needed to be at least one family member (age 13 or older) residing in the home with them. Group III represented individuals recruited at a participating community based organization where members of the entire organization were invited to enroll. At enrollment participant’s height, weight and waist circumference were measured. After completion of the baseline assessment participants were randomized to one of two treatment arms. If a social network member was recruited they were placed in the same intervention arm that the index participant was randomized to in order to prevent contamination. The same rationale applied to community sites, the site was the unit of randomization. These three recruitment groupings were designed to assess whether involvement of different forms of the social network would enhance the efficacy of the intervention. A detailed description of the flow of participants from screening to completion at 12 month follow up is shown in Figure 2. The baseline assessment and goal setting interview were conducted in one session. Follow up sessions were conducted on the phone or in person, based on the participants preferences weekly during months 1–3, biweekly during months 4 to 9 and monthly during months 10–12. At each follow-up CHW’s assessed for adherence to the eating and physical activity strategies as number of days in the past week that a participant was able to do each one. For those randomized to the PA/SA CHW’s also assessed how many days in the past week the participant used each component. At month 3 all participants were given an individualized scale for self- monitoring of their weight. They were asked to check their weight at least monthly and report the weight to their CHW during the regular follow-up. The final assessment was done in person. Table 3 depicts the measures obtained at each follow up during the RCT.
Affiliation: Division of Clinical Epidemiology and Evaluative Science Research, Weill Cornell Medical College 338 East 66th Street New York, NY 10065; School of Applied Economics and Management, Cornell University 201 Warren Hall Cornell University, Ithaca, NY 14853-7801. Electronic address: firstname.lastname@example.org.