ENGAGED: E-Networks Guiding Adherence to Goals for Exercise and Diet
ENGAGED
1 other identifier
interventional
96
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 obesity
Started Jul 2011
Typical duration for phase_1 obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 15, 2010
CompletedFirst Posted
Study publicly available on registry
January 18, 2010
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedNovember 11, 2016
November 1, 2016
1.8 years
January 15, 2010
November 10, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weight loss
3 months, 6 months, 12 months
Secondary Outcomes (1)
Behavioral adherence
3 months, 6 months
Study Arms (3)
Standard
EXPERIMENTALThose 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.
Technology Supported condition
EXPERIMENTALThose 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.
Self-Guided
NO INTERVENTIONParticipants in the Self-Guided condition will receive DPP DVDs (3 DVDs and 1 CD) at the beginning of the study. This condition will not receive any direct dietary or physical activity interventions outside of the DVDs. Although Self-Guided participants will be receiving the same 7% weight loss goal as the other two groups, they will not be receiving physical activity or diet goals. The DVDs cover the initial 12-weekly sessions of the DPP, with the sessions portrayed by professional actors. They will also be provided with a supplemental DVD which includes a manual for each of the 12 sessions. They will also be giving the Keeping Track booklets and asked to record their diet and activity daily.
Interventions
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.
Eligibility Criteria
You may qualify if:
- BMI between 30-40
- weight stable (not gained/lost more than 25 lbs in the past 6 months)
- not enrolled in any formal weight-loss program
- interested in losing weight
- willing and able to record dietary intake and weight for 6 months and wear an accelerometer
- willing to attend 8 weekly groups and 2 follow up assessments at the Northwestern Chicago campus
- expect to reside in the Chicago land area for the next 12 months
You may not qualify if:
- any unstable medical conditions (i.e. uncontrolled hypertension, diabetes, unstable angina pectoris, myocardial infarction, transient ischemic attack, cancer undergoing active treatment, a cerebrovascular accident within the past 6 months)
- history of insulin-dependent diabetes
- Crohn's disease
- diagnosis of obstructive sleep apnea requiring intervention
- required use of an assistive device for mobility (i.e. cane, wheelchair)
- BMI \> 40
- hospitalization for a psychiatric disorder within the past 5 years
- those at risk for adverse cardiovascular events with moderate intensity activity
- those currently taking weight loss medication or committed to following an incompatible dietary regimen
- women who are pregnant, trying to get pregnant, or lactating
- Bulimia Nervosa
- suicide ideation
- current binge eating disorder
- those currently taking medications known to cause weight gain (i.e. Prednisone, Depakote, Diebeta, Diabinese, Cardura, Inderal, Zyprexa)
- current substance abuse or dependence
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northwestern Universitylead
- Illinois Institute of Technologycollaborator
Study Sites (1)
Northwestern University
Chicago, Illinois, 60611, United States
Related Publications (2)
Spring B, Pellegrini CA, Pfammatter A, Duncan JM, Pictor A, McFadden HG, Siddique J, Hedeker D. Effects of an abbreviated obesity intervention supported by mobile technology: The ENGAGED randomized clinical trial. Obesity (Silver Spring). 2017 Jul;25(7):1191-1198. doi: 10.1002/oby.21842. Epub 2017 May 11.
PMID: 28494136DERIVEDPellegrini CA, Duncan JM, Moller AC, Buscemi J, Sularz A, DeMott A, Pictor A, Pagoto S, Siddique J, Spring B. A smartphone-supported weight loss program: design of the ENGAGED randomized controlled trial. BMC Public Health. 2012 Nov 30;12:1041. doi: 10.1186/1471-2458-12-1041.
PMID: 23194256DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bonnie Spring, Ph.D.
Northwestern University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Preventive Medicine, Psychology, and Psychiatry
Study Record Dates
First Submitted
January 15, 2010
First Posted
January 18, 2010
Study Start
July 1, 2011
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
November 11, 2016
Record last verified: 2016-11