Opt-IN: Optimization of Remotely Delivered Intensive Lifestyle Treatment for Obesity

Northwestern University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Weight Loss

Treatments: Behavioral: Report to Primary Care Physician; Behavioral: Buddy Training; Behavioral: 12 Telephone Coaching Sessions; Behavioral: 24 Telephone Coaching Sessions; Behavioral: Recommendations to use meal replacements; Behavioral: Text Messages

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01814072

NIH NIDDK R01DK097364-01

R01DK097364-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The overall objective of the proposed research is to use an innovative methodological framework, the Multiphase Optimization Strategy (MOST), to design, for the first time, an optimized, scalable version of a technology-supported intensive lifestyle intervention (INLI) for obesity. MOST involves highly efficient randomized experimentation to assess the effects of individual treatment components, and thereby identify which components and component levels make important contributions to the overall program effect on weight loss. This information then guides assembly of an optimized treatment package that achieves target outcomes with least resource consumption and participant burden. Because the intervention strategies being tested minimize in-person coaching and leverage technology that participants already own, the new optimized intervention, to be called Opt-IN, will be more scalable than traditional INLIs. Opt-IN will thus enjoy greatly increased reach, and enable significant progress in the fight against obesity.

Full description

The goal of the proposed study is to determine the optimal composition of a technology supported intervention for obesity that minimizes expense and burden to participants, while achieving 6 month weight loss outcomes comparable or superior to those achieved by the current full cost, full burden form of INLIs. All intervention components to be examined were selected based on the Opt-IN model's prediction that they enhance behavioral adherence to weight regulation via the designated pathways. The five components to be tested will be: (1) coaching intensity (12 vs. 24 phone sessions), (2) text messaging (No vs. Yes), (3) progress report to participant's primary care provider (No vs. Yes), (4) recommendation to use meal replacements (No vs. Yes), (5) training participants' self-selected buddies to be supportive (No vs. Yes).

Enrollment: 562 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 and 60 years old
• BMI 25-40 kg/m2
• Weight stable (no loss or gain >25 lbs for the past 6 months)
• Not enrolled in any formal weight loss program or taking anti-obesity medications, but interested in losing weight.
• Own a Smartphone and be willing to install the Opt-IN app
• Able to use the app to record dietary intake and weight onto the Smartphone

"Buddy" participants must:

• 18 years of age or older
• Have access to a computer and internet
• Be willing to undergo "Buddy Training" and participate in 4 webinars
• Be willing to provide support and encouragement to the participant

Exclusion criteria

• Unstable medical conditions (uncontrolled hypertension, diabetes, unstable angina pectoris, myocardial infarction, transient ischemic attack, cancer undergoing active treatment, or cerebrovascular accident within the past six months)
• History of diabetes requiring insulin supplementation, Crohn's Disease, or a diagnosis of obstructive sleep apnea requiring intervention (i.e. CPAP)
• Use an assistive device for mobility (e.g., wheelchair, walker, cane)
• Plantar fasciitis
• Hospitalization for a psychiatric disorder within the past 5 years
• At risk for adverse cardiovascular (CVD) events with moderate intensity activity
• Cannot read the study questionnaires
• Committed to following an incompatible dietary regimen
• Not be pregnant, trying to get pregnant, or lactating
• Bulimia, binge eating disorder, current substance abuse or dependence (besides nicotine dependence) or report active suicidal ideation
• Low motivation to change
• Cannot live with a current or past Opt-IN participant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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562 participants in 32 patient groups

Condition 1

Experimental group

Description:

1) Lifestyle Core; 2) 12 Telephone Coaching Sessions; 3) Report to Primary Care Physician

Treatment:

Behavioral: 12 Telephone Coaching Sessions

Behavioral: Report to Primary Care Physician

Condition 2

Experimental group

Description:

1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendations to use meal replacements; 5) Buddy training via webinars

Treatment:

Behavioral: 12 Telephone Coaching Sessions

Behavioral: Report to Primary Care Physician

Behavioral: Buddy Training

Behavioral: Recommendations to use meal replacements

Condition 3

Experimental group

Description:

1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages; 5) Buddy training via webinars

Treatment:

Behavioral: 12 Telephone Coaching Sessions

Behavioral: Report to Primary Care Physician

Behavioral: Buddy Training

Behavioral: Text Messages

Condition 4

Experimental group

Description:

1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages

Treatment:

Behavioral: 12 Telephone Coaching Sessions

Behavioral: Report to Primary Care Physician

Behavioral: Text Messages

Behavioral: Recommendations to use meal replacements

Condition 5

Experimental group

Description:

1) Lifestyle Core; 2) 12 telephone sessions; 3) Buddy training via webinars

Treatment:

Behavioral: 12 Telephone Coaching Sessions

Behavioral: Buddy Training

Condition 6

Experimental group

Description:

1) Lifestyle Core; 2) 12 telephone coaching sessions; 3) Recommendations to use meal replacements

Treatment:

Behavioral: 12 Telephone Coaching Sessions

Behavioral: Recommendations to use meal replacements

Condition 7

Experimental group

Description:

1) Lifestyle Core; 2) 12 telephone sessions; 3) Regular text messages

Treatment:

Behavioral: 12 Telephone Coaching Sessions

Behavioral: Text Messages

Condition 8

Experimental group

Description:

1) Lifestyle Core; 2) 12 telephone sessions; 3) Recommendation to use meal replacements; 4) Regular text messages, 5) Buddy training via webinars

Treatment:

Behavioral: 12 Telephone Coaching Sessions

Behavioral: Buddy Training

Behavioral: Text Messages

Behavioral: Recommendations to use meal replacements

Condition 9

Experimental group

Description:

1) Lifestyle Core; 2) 24 telephone coaching sessions; 3) Report to Primary Care Physician

Treatment:

Behavioral: Report to Primary Care Physician

Behavioral: 24 Telephone Coaching Sessions

Condition 10

Experimental group

Description:

1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Buddy training via webinars

Treatment:

Behavioral: Report to Primary Care Physician

Behavioral: Buddy Training

Behavioral: 24 Telephone Coaching Sessions

Behavioral: Recommendations to use meal replacements

Condition 11

Experimental group

Description:

1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages; 5) Buddy training via webinars

Treatment:

Behavioral: Report to Primary Care Physician

Behavioral: Buddy Training

Behavioral: 24 Telephone Coaching Sessions

Behavioral: Text Messages

Condition 12

Experimental group

Description:

1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages

Treatment:

Behavioral: Report to Primary Care Physician

Behavioral: 24 Telephone Coaching Sessions

Behavioral: Text Messages

Behavioral: Recommendations to use meal replacements

Condition 13

Experimental group

Description:

1) Lifestyle Core; 2) 24 telephone sessions; 3) Buddy training via webinars

Treatment:

Behavioral: Buddy Training

Behavioral: 24 Telephone Coaching Sessions

Condition 14

Experimental group

Description:

1) Lifestyle Core; 2) 24 telephone coaching sessions; 3) Recommendation to use meal replacements

Treatment:

Behavioral: 24 Telephone Coaching Sessions

Behavioral: Recommendations to use meal replacements

Condition 15

Experimental group

Description:

1) Lifestyle Core; 2) 24 telephone sessions; 3) Regular text messages

Treatment:

Behavioral: 24 Telephone Coaching Sessions

Behavioral: Text Messages

Condition 16

Experimental group

Description:

1) Lifestyle Core; 2) 24 telephone sessions; 3) Recommendation to use meal replacements; 4) Regular text messages, 5) Buddy training via webinars

Treatment:

Behavioral: Buddy Training

Behavioral: 24 Telephone Coaching Sessions

Behavioral: Text Messages

Behavioral: Recommendations to use meal replacements

Condition 17

Experimental group

Description:

1) Lifestyle Core; 2) 12 Telephone Coaching Sessions

Treatment:

Behavioral: 12 Telephone Coaching Sessions

Condition 18

Experimental group

Description:

1) Lifestyle Core; 2) 12 telephone sessions; 3) Recommendations to use meal replacements; 4) Buddy training via webinars

Treatment:

Behavioral: 12 Telephone Coaching Sessions

Behavioral: Buddy Training

Behavioral: Recommendations to use meal replacements

Condition 19

Experimental group

Description:

1) Lifestyle Core; 2) 12 telephone sessions; 3) Regular text messages; 4) Buddy training via webinars

Treatment:

Behavioral: 12 Telephone Coaching Sessions

Behavioral: Buddy Training

Behavioral: Text Messages

Condition 20

Experimental group

Description:

1) Lifestyle Core; 2) 12 telephone sessions; 3) Regular text messages; 4) Recommendation to use meal replacements

Treatment:

Behavioral: 12 Telephone Coaching Sessions

Behavioral: Text Messages

Behavioral: Recommendations to use meal replacements

Condition 21

Experimental group

Description:

1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Buddy training via webinars

Treatment:

Behavioral: Report to Primary Care Physician

Behavioral: Buddy Training

Condition 22

Experimental group

Description:

1) Lifestyle Core; 2) 12 telephone coaching sessions; 3) Report to Primary Care Physician; 4) Recommendations to use meal replacements

Treatment:

Behavioral: Report to Primary Care Physician

Condition 23

Experimental group

Description:

1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages

Treatment:

Behavioral: 12 Telephone Coaching Sessions

Behavioral: Report to Primary Care Physician

Behavioral: Text Messages

Condition 24

Experimental group

Description:

1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages, 6) Buddy training via webinars

Treatment:

Behavioral: 12 Telephone Coaching Sessions

Behavioral: Report to Primary Care Physician

Behavioral: Buddy Training

Behavioral: Text Messages

Behavioral: Recommendations to use meal replacements

Condition 25

Experimental group

Description:

1) Lifestyle Core; 2) 24 telephone coaching sessions

Treatment:

Behavioral: 24 Telephone Coaching Sessions

Condition 26

Experimental group

Description:

1) Lifestyle Core; 2) 24 telephone sessions; 3) Recommendation to use meal replacements; 4) Buddy training via webinars

Treatment:

Behavioral: Buddy Training

Behavioral: 24 Telephone Coaching Sessions

Behavioral: Recommendations to use meal replacements

Condition 27

Experimental group

Description:

1) Lifestyle Core; 2) 24 telephone sessions; 3) Regular text messages; 4) Buddy training via webinars

Treatment:

Behavioral: Buddy Training

Behavioral: 24 Telephone Coaching Sessions

Behavioral: Text Messages

Condition 28

Experimental group

Description:

1) Lifestyle Core; 2) 24 telephone sessions; 3) Regular text messages; 4) Recommendation to use meal replacements

Treatment:

Behavioral: 24 Telephone Coaching Sessions

Behavioral: Text Messages

Behavioral: Recommendations to use meal replacements

Condition 29

Experimental group

Description:

1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Buddy training via webinars

Treatment:

Behavioral: Report to Primary Care Physician

Behavioral: Buddy Training

Behavioral: 24 Telephone Coaching Sessions

Condition 30

Experimental group

Description:

1) Lifestyle Core; 2) 24 telephone coaching sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements

Treatment:

Behavioral: Report to Primary Care Physician

Behavioral: 24 Telephone Coaching Sessions

Behavioral: Recommendations to use meal replacements

Condition 31

Experimental group

Description:

1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages

Treatment:

Behavioral: Report to Primary Care Physician

Behavioral: 24 Telephone Coaching Sessions

Behavioral: Text Messages

Condition 32

Experimental group

Description:

1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages, 6) Buddy training via webinars

Treatment:

Behavioral: Report to Primary Care Physician

Behavioral: Buddy Training

Behavioral: 24 Telephone Coaching Sessions

Behavioral: Text Messages

Behavioral: Recommendations to use meal replacements