Meghan L. Butryn, Ph.D. - US grants

DESCRIPTION (provided by applicant): Environmental and Acceptance-Based Innovations for Weight Loss Maintenance Obesity is a serious and prevalent health problem with widespread medical, psychosocial and economic consequences. Although behavior therapy (BT) is the gold standard among non-surgical approaches, weight regain usually begins shortly after treatment ends;nearly all of weight lost in these programs is regained by 5 years after treatment. Several factors appear to make weight loss maintenance challenging including the obesogenic food environment, the rewarding value of food, and labor-saving devices and a built environment that reduce energy expenditure. One promising way of improving BT programs is to teach participants how to modify their personal food and physical activity environment so that it provides maximal support for desirable weight control behaviors. Intervention components can include modifying the type, nutritional composition, variety, and portion size of food available at home;modifying the availability of exercise equipment and sedentary activities in the home;increasing the saliency of the consequences of eating and exercise choices;and obtaining support for environmental changes. A second innovative way of improving BT programs is to incorporate components of Acceptance and Commitment Therapy (ACT) in order to (a) bolster participants'commitment to behavior change, (b) build distress tolerance skills, and (c) promote mindful awareness of weight-related behaviors and goals. Such skills should improve long-term adherence to dietary and physical activity recommendations (and therefore weight loss maintenance). We expect that there will be a synergy and a complementary nature between these treatment components and the environmental treatment components. Maintaining a home environment that facilitates weight control requires commitment, distress tolerance, and awareness, because individuals must make decisions about environmental modifications and maintain these modifications. Additionally, there are limits to the home environment approach because individuals will continue to encounter many challenging situations in which they cannot modify the environment to any meaningful extent;acceptance-based skills may promote healthy choices in such challenging situations. As a test of the combined approach, participants will be randomly assigned to one of three conditions: 1)BT, 2) BT plus modifying the home environment (BT+E), or 3) BT plus modifying the home environment and training in acceptance-based skills (BT+EA). Treatment will last 1 year. Participants will be 297 overweight and obese individuals recruited from the community. Thirty percent of participants will be ethnic minorities. Assessments will be completed at baseline and Months 6, 12 (end of treatment), 18 (i.e., 6-month follow-up), and 24 (i.e., 12- month follow-up). The primary aim of the study is to test the hypothesis that participants in the BT+EA condition will maintain more weight loss than those in the BT condition at 12-month follow-up. Secondary aims will compare weight loss in BT+EA vs. BT+E, and BT+E vs. BT, and examine dietary intake and physical activity as outcomes. Exploratory aims will examine mediation and moderation of treatment outcome. PUBLIC HEALTH RELEVANCE: Obesity is a condition that can impair health and quality of life. One of the biggest challenges in addressing the obesity epidemic is determining ways to help individuals maintain weight losses. This study is designed to test an innovative treatment that may improve weight loss maintenance.

DESCRIPTION (provided by applicant): Obesity is causally linked with numerous health problems. State-of-the-art behavioral interventions for obesity reliably facilitate clinically significant weight loss in the short-term, but weight regain (and a return to elevated disease risk is normative. Innovative interventions that improve long-term outcomes of lifestyle modification must be developed and tested. New evidence suggests that a high level of physical activity (PA) is a critical component of weight loss maintenance (and has numerous ancillary health benefits, independent of weight). Most adults who are prescribed high levels of PA (whether as part of a weight management program or other intervention) do not ultimately adhere to these prescriptions, suggesting that traditional behavioral skills and intervention strategies are not sufficiently matched to the challenges of this critical, long-term behavior change. Theoretical and empirical work strongly suggest that for obese adults to be successful at consistently engaging in high levels of PA they must employ specific psychological skills, including mindful decision-making, behavioral commitment in the face of challenges, an ability to tolerate physical and psychological discomfort, and an ability to achieve clarity about one's personal values. These skills are the focus of acceptance-based behavioral interventions for PA promotion. To test the effectiveness of this approach, this study will recruit 300 adults from the community and provide them with 6 months of group-based standard behavioral weight loss treatment (Phase I). In Phase II, participants will receive one of three interventions, to be delivered for an additional 12 months: 1) behavioral treatment, with the standard emphasis on maintaining changes in diet and PA (BT), 2) behavioral treatment, with a primary emphasis on using these skills to maintain PA (BT-PA), or 3) acceptance-based behavioral treatment, with a primary emphasis on using these skills to maintain PA (ABT- PA). The PA prescription will be uniform across conditions. All participants will be encouraged to gradually progress to and subsequently maintain an amount of PA that will result in 2000 kcal/wk of energy expenditure. Assessments will be conducted at baseline, 6 months (end of Phase I treatment), 18 months (end of Phase II treatment), 24 months (6-month follow-up), and 36 months (18-month follow-up). An intensive focus on PA after initial weight loss (i.e., BT-PA and ABT-PA) is hypothesized to result in a) better weight loss maintenance, and b) higher amounts of PA at post-treatment and follow-up compared to standard behavioral treatment (BT). An intensive focus on PA after initial weight loss is also hypothesized to result in a) better weight loss maintenance and b) higher amounts of PA at post-treatment and follow-up when acceptance-based behavioral skills are taught (i.e., ABT-PA), compared to when standard behavioral skills are taught (BT-PA). Theory- driven mediators and moderators of intervention effects also will be examined. Accomplishing these aims will advance research on health-related behavior change and has the potential to meaningfully impact the behavioral prevention and treatment of many obesity-related diseases and conditions.

DESCRIPTION (provided by applicant): Obesity is causally linked with numerous health problems. State-of-the-art behavioral interventions for obesity reliably facilitate clinically significant weight loss in the short-term, but weight regain (and a return to elevated disease risk is normative. Innovative interventions that improve long-term outcomes of lifestyle modification must be developed and tested. New evidence suggests that a high level of physical activity (PA) is a critical component of weight loss maintenance (and has numerous ancillary health benefits, independent of weight). Most adults who are prescribed high levels of PA (whether as part of a weight management program or other intervention) do not ultimately adhere to these prescriptions, suggesting that traditional behavioral skills and intervention strategies are not sufficiently matched to the challenges of this critical, long-term behavior change. Theoretical and empirical work strongly suggest that for obese adults to be successful at consistently engaging in high levels of PA they must employ specific psychological skills, including mindful decision-making, behavioral commitment in the face of challenges, an ability to tolerate physical and psychological discomfort, and an ability to achieve clarity about one's personal values. These skills are the focus of acceptance-based behavioral interventions for PA promotion. To test the effectiveness of this approach, this study will recruit 300 adults from the community and provide them with 6 months of group-based standard behavioral weight loss treatment (Phase I). In Phase II, participants will receive one of three interventions, to be delivered for an additional 12 months: 1) behavioral treatment, with the standard emphasis on maintaining changes in diet and PA (BT), 2) behavioral treatment, with a primary emphasis on using these skills to maintain PA (BT-PA), or 3) acceptance-based behavioral treatment, with a primary emphasis on using these skills to maintain PA (ABT- PA). The PA prescription will be uniform across conditions. All participants will be encouraged to gradually progress to and subsequently maintain an amount of PA that will result in 2000 kcal/wk of energy expenditure. Assessments will be conducted at baseline, 6 months (end of Phase I treatment), 18 months (end of Phase II treatment), 24 months (6-month follow-up), and 36 months (18-month follow-up). An intensive focus on PA after initial weight loss (i.e., BT-PA and ABT-PA) is hypothesized to result in a) better weight loss maintenance, and b) higher amounts of PA at post-treatment and follow-up compared to standard behavioral treatment (BT). An intensive focus on PA after initial weight loss is also hypothesized to result in a) better weight loss maintenance and b) higher amounts of PA at post-treatment and follow-up when acceptance-based behavioral skills are taught (i.e., ABT-PA), compared to when standard behavioral skills are taught (BT-PA). Theory- driven mediators and moderators of intervention effects also will be examined. Accomplishing these aims will advance research on health-related behavior change and has the potential to meaningfully impact the behavioral prevention and treatment of many obesity-related diseases and conditions.

Abstract In a lifestyle modification program, contact with an interventionist (e.g., weight loss coach) creates a sense of supportive accountability that can facilitate behavior change and weight loss. Sustaining a strong sense of supportive accountability after face-to-face intervention contact ends has the potential to improve outcomes during the notoriously difficult weight loss maintenance period. One innovative way of facilitating supportive accountability is providing participants with digital tools that objectively measure weight and PA and track food intake in real-time, making the data from those tools automatically and continuously available to coaches, and designing the timing and content of intervention contacts such that they are responsive to the shared data. Although tools that allow for data sharing from sensors and Internet-based applications are readily available, the ways in which they are integrated into intervention contacts in a lifestyle modification program are not yet optimized, and research has not systematically evaluated the effect of data sharing on behavior. Overweight and obese participants (n = 90) will be recruited from the community for a small RCT in order to test the feasibility, acceptability, efficacy, and mechanisms of action of a lifestyle modification intervention enhanced with data sharing. In weeks 1-12 of the program (i.e., Phase I), all participants will attend 12 weekly, face-to- face, group-based behavioral treatment sessions to induce weight loss. Participants will be provided with a wireless body weight scale, PA sensor, and digital food record app and instructed to use them daily use for self-monitoring purposes. In Phase II (weeks 13-52), participants will be randomly assigned to the standard (LM) or enhanced version of remote lifestyle modification (LM+SHARE). Neither condition will have face-to- face intervention contact during Phase II; remote intervention contact will consist of brief phone calls and text messages provided by the participant's coach. Participants in both conditions will be prescribed continued daily use of the three self-monitoring devices. In the standard LM condition, no digital data from these devices will be directly shared with coaches; intervention encounters will be informed only by the infrequent, delayed self- report of participants (which is the current standard of long-term obesity care), and timing of text messages will be fixed. In LM+SHARE, the digital tools will automatically and continuously transmit body weight, PA, and food record data to the coach. In LM+SHARE, supportive accountability will be enhanced in three ways: 1) participants will receive automated alerts after coaches view their data, 2) timing of personalized text messages from coaches will be responsive to clinically notable change in weight, PA, calorie intake, or use of scale, PA sensor, or food record tool, and 3) content of the text messages and phone calls will be informed by the digital data the coach has viewed, as well as the expectation that the coach will continue viewing data in order to provide ongoing support. Assessments will be completed at 0, 12, 26, 40, and 52 weeks.

Abstract Dietary intake is a powerful, modifiable factor that influences cancer risk. Unfortunately, most adults in the U.S. find it difficult to adhere to dietary guidelines for cancer prevention. One promising pathway for improving dietary adherence is to target grocery shopping habits, i.e., foods purchased for consumption at home. Two- thirds of daily food intake is sourced from or eaten in the home, so improving the quality of the home food environment should improve overall diet quality. When healthy foods are purchased and unhealthy foods are not, minimal self-control is needed to make healthy eating choices in the home. At the point of purchase, it is difficult to resist the temptation of palatable foods, but interventions might facilitate healthy choices by a) promoting dietary goal salience in real-time while grocery shopping, b) enhancing motivation to make and sustain changes to the diet, and c) increasing household support and accountability for healthy food purchasing. At this stage of research, methodical testing of intervention components that can change food purchase behaviors is needed, in order to craft an mHealth intervention package that is feasible, acceptable, and optimized for efficacy and scalability. The proposed study will enroll adults (N = 64) who have low adherence to cancer prevention dietary recommendations. All participants will attend a 3-hour nutrition education workshop. For 6 months following the workshop, all participants will receive text notifications that provide tailored reminders and recommendations for food purchasing. The study will use a factorial design to experimentally test four additional intervention components and examine their feasibility, acceptability, and effect on food purchases and dietary intake at 3 and 6 months. (Each component is randomly assigned to be activated for 50% of participants.) The four components to be tested are: 1) Location-triggered text notifications: Reminders and recommendations for food purchases are delivered ?just-in-time,? when arriving at grocery shopping locations, to enhance goal salience. 2) Reflections on the benefits of change: To enhance motivation, content is added to messages to encourage reflection on the anticipated benefits of healthy eating. 3) Coach monitoring: Food purchases are automatically monitored by a coach (through a system that collects item-level store data) who sends personalized post-purchase messages designed to enhance supportive accountability and thus motivation. 4) Household text: Other adults in the household receive messages designed to elicit support for healthy food purchasing and provide another source of supportive accountability. The preliminary aim of the study is to assess feasibility and acceptability of the intervention components. The primary aim of the study is to quantify the effect of each intervention component, individually and in combination, on grocery store food purchases (objectively assessed with store data), and dietary intake (assessed with 24-hour food recalls). Mediation analyses also will be conducted. The overarching goal of this project is to optimize this mHealth intervention, which can be tested in the future in a fully powered clinical trial.

Abstract Adults attempting weight loss through lifestyle modification (LM) typically find maintenance of behavior change difficult. Outcomes might be improved if participants are provided with sustained sources of accountability and support and ongoing opportunities to reflect with others on goal progress. This study proposes that sharing digital data (i.e., body weight from wireless scale, physical activity from wearable sensor, and dietary intake from smartphone app) with other parties has the potential to improve long-term weight loss. The benefit of device data sharing has not yet been rigorously tested, and traditional LM programs do not yet incorporate digital data sharing in a systematic way. The proposed study will enroll adults (N = 320) with overweight/ obesity in a 24-month LM program and instruct them to use digital tools for self-monitoring of weight, physical activity, and eating on a daily basis. Groups will meet face-to-face weekly in months 1-3 to initiate weight loss. In months 4-24, intervention contact will be remote and will include the following: quarterly group meetings held via videoconference; brief phone calls with the coach held twice per quarter; and monthly text messages with the coach, with a small group of fellow group participants, and with a friend or family member outside of the program. A 2 x 2 x 2 factorial design will test the independent effects of three types of data sharing partnerships: Coach Share, Group Share, and Friend/Family Share. Half of the participants will receive Coach Share and half will not; half will receive Group Share and half will not; and half will receive Friend/Family Share and half will not. In Coach Share, the behavioral coach will view digital self-monitoring data throughout the program and will directly address data observations during intervention contacts. In Group Share, participants in a given LM group will view each other?s self-monitoring data in their small-group text messages. In Friend/Family Share, a friend or family member outside of the group will view the participant?s data via automated text message. Each party with whom data are shared will be trained to respond by eliciting reflection from the index participant on his/her goal progress, which is a key component of self-regulation, and supporting the participant?s motivation to meet program goals. Amount of intervention contact between the participant and each party (Coach, Group, Friend/Family) will be comparable across treatment conditions, isolating the effects of data sharing components. Outcomes will be measured at months 0, 6, 12, and 24. The study will determine if Coach Share, Group Share, and Friend/Family Share each improve long-term weight loss, PA, and calorie intake (i.e., outcomes will be compared for participants who are randomized to engage in that data sharing partnership, versus those who are not). The study also will examine if effects are additive when participants are assigned to engage in more than one type of data sharing partnership. Mediators and moderators of intervention effects will be examined. As digital technology makes data sharing increasingly feasible, it is critical to determine how to optimize these partnerships to improve long-term outcomes in LM.