ENGAGED: E-Networks Guiding Adherence to Goals for Exercise and Diet
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The ENGAGED study is a 12-month randomized controlled trial investigating different
      strategies to improve weight loss in overweight individuals. All participants will receive an
      effective weight loss treatment: either self-guided or group formats. All treatment will be
      provided in the Department of Preventive Medicine at Northwestern University. Participants
      who receive the self-guided weight loss treatment will be provided with a weight loss manual
      that contains proven behavioral weight loss strategies. Those participants who receive the
      group treatment will take part in 8 weekly, 90 minute group sessions in our clinic at 680 N.
      Lakeshore Dr., Chicago, IL 60048. Some participants will also be assigned an individual
      coach, who will communicate with them regularly via phone, email, and/or text message for the
      duration of the study. All participants must be willing and able to record food and beverage
      intake (either on a smartphone or on paper) and be willing to wear a small and unobtrusive
      physical activity measurement device for the first six-months of the study. Additionally, all
      participants will be asked to attend 3 follow-up assessment visits at our clinic at months 3,
      6 and 12 after the study begins. Participants will be compensated for completing each of the
      3 follow-up assessments. All participants will be part of a team weight loss competition at 3
      and 6 months with financial incentive to be split evenly among the winning team.
    

Detailed description: 
      The Diabetes Prevention Program (DPP) intensive lifestyle intervention is the gold standard
      weight loss treatment for adults with cardiometabolic risk factors. Despite its efficacy, the
      DPP has not been widely adopted, because its 16 individual, face-to-face sessions with a
      specialist are considered too burdensome and expensive to be a sustainable program. Attempts
      to reduce cost by decreasing session number have yielded greatly diminished weight loss.
      Behavioral adherence to diet and activity goals declines and weight regain routinely begins
      once frequent face-to-face meetings cease. The still unmet challenge of DPP implementation is
      how to reduce treatment intensity without excising the regular social support,
      accountability, and feedback that are essential to maintain adherence. We hypothesize that it
      is feasible to implement DPP Intensive Lifestyle Treatment as effectively but twice as
      efficiently by using hand held technology to preserve feedback, accountability, and regular
      social support. The smartphone-based technology system to be tested is guided by Carver and
      Scheier's control systems theory of self-regulation. Initial formative research will upgrade
      the smartphone with engaging features that motivate participants to use the device to
      self-monitor and interact with a coach and peer support group. Use of the finalized tool will
      be compared to usual recording on paper records in a preliminary 3-group randomized
      controlled trial (RCT) involving 96 obese adults. By enabling peer support, accountability,
      and feedback on diet, physical activity, and weight loss goals continuously through the
      6-month intervention period, the ENGAGED system is expected to enhance (1) behavioral
      adherence [operationalized by (a) self-monitoring of diet and activity and (b) attainment of
      diet and activity goals], and (2) weight loss. An enabling technology that integrates
      specialist and peer support resources to improve treatment adherence could help to curtail
      the obesity epidemic by increasing the efficiency, feasibility, and reach of effective DPP
      lifestyle intervention.
    

Intervention name(s): Technology Supported; Standard
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Those randomized to the Technology Supported condition will record dietary intake and weight on the smartphone, using the user-friendly, persuasive interface developed in Phase I. They will be expected to enter their dietary intake into the smartphone daily throughout the day. They will also be expected to enter their weight and to wear the accelerometer daily. Time-stamped data from the smartphone will upload automatically to the study server throughout the day, where it will be visible to the lifestyle coach. The participant's real-time diet, activity, and weight data relative to goals will also be visually depicted on the participant's smartphone. The anticipated web platform will be developed specifically for the ENGAGED participants. The coach will provide feedback on diet and activity self-monitoring and goal adherence at least weekly by phone, e-mail or text during weeks 1-8 and then at least monthly through the 6 month follow-up.; Those randomized to the Standard condition will record everything they eat and will total their daily fat grams and calories on the "Keeping Track" form used in the DPP. They will turn in their self-monitoring diaries and download their accelerometer (but not see those data) at weekly group sessions 1 through 8. Thereafter they will be expected to turn in paper data monthly, in person at the months 3 and 6 assessments and via mail, fax or e-mail for months 4 and 5. Accelerometer data will be downloaded at in-person visits.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: obesity; behavioraladherence; weight loss; smartphone