SMART Weight Loss Management
| Status: | Recruiting |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 2/16/2018 |
| Start Date: | June 19, 2017 |
| End Date: | March 2021 |
| Contact: | Laura Martindale, MS |
| Email: | laura.martindale@northwestern.edu |
| Phone: | 312-503-1395 |
The overall objective of this study is to use an innovative experimental approach, the SMART
(Sequential Multiple Assignment Randomized Trial), to determine the best way to sequence the
delivery of mHealth tools and traditional treatment components in a stepped program of
obesity treatments. The SMART approach is a highly efficient strategy for identifying and
constructing efficacious adaptive interventions: it accommodates sequential decision-making
based on the participant's response to early weight loss treatment components. The proposed
treatment package begins with the least expensive components, and for participants identified
as treatment non-responders, provides sequential step-up of additional treatment components.
By sequentially delivering treatment components based on participant response, SMART permits
achievement of the target outcome, weight loss, with least resource consumption and
participant burden.
(Sequential Multiple Assignment Randomized Trial), to determine the best way to sequence the
delivery of mHealth tools and traditional treatment components in a stepped program of
obesity treatments. The SMART approach is a highly efficient strategy for identifying and
constructing efficacious adaptive interventions: it accommodates sequential decision-making
based on the participant's response to early weight loss treatment components. The proposed
treatment package begins with the least expensive components, and for participants identified
as treatment non-responders, provides sequential step-up of additional treatment components.
By sequentially delivering treatment components based on participant response, SMART permits
achievement of the target outcome, weight loss, with least resource consumption and
participant burden.
The proposed study seeks to develop an effective, resource-sensitive strategy to manage
weight loss treatment for obesity. During the 12-week active intervention phase, participants
will be randomized to one of two first-line treatments: 1) mobile app alone (APP) or 2) app
plus weekly telephone coaching sessions (APP+C). Beginning at week 2, those who are
identified as treatment non-responders (did not lose an average of 0.5 lbs/week) will be
re-randomized to one of two augmentation tactics: 1) Modest Step-up, operationalized as the
addition of an additional mHealth component, or 2) Vigorous Step-up, operationalized as the
addition of an additional mHealth component plus a traditional weight loss intervention
component. Treatment responders will continue with the same first-line treatment. Treatment
response be re-assessed at weeks 4 and 8. Those identified as treatment non-responders will
be re-randomized at that time.
weight loss treatment for obesity. During the 12-week active intervention phase, participants
will be randomized to one of two first-line treatments: 1) mobile app alone (APP) or 2) app
plus weekly telephone coaching sessions (APP+C). Beginning at week 2, those who are
identified as treatment non-responders (did not lose an average of 0.5 lbs/week) will be
re-randomized to one of two augmentation tactics: 1) Modest Step-up, operationalized as the
addition of an additional mHealth component, or 2) Vigorous Step-up, operationalized as the
addition of an additional mHealth component plus a traditional weight loss intervention
component. Treatment responders will continue with the same first-line treatment. Treatment
response be re-assessed at weeks 4 and 8. Those identified as treatment non-responders will
be re-randomized at that time.
Inclusion Criteria:
- 18 through 60 years old
- BMI between 27 - 45 kg/m2
- < 350 lbs
- Weight stable (no loss or gain >25 lbs. for the past 6 months)
- Interested in losing weight and not enrolled in a formal weight loss program or taking
medications or supplements that may cause weight change
- Own a Smartphone and be willing to install the SMART App
- Reside in the Chicago area for the duration of their participation (12 months)
Exclusion Criteria:
- Unstable medical conditions (uncontrolled hypertension, diabetes - uncontrolled or
treated with insulin, uncontrolled hypothyroidism, unstable angina pectoris, transient
ischemic attack, cancer undergoing active treatment, cerebrovascular accident or
myocardial infarction within the past six months, or Crohn's disease)
- Pregnancy, lactation, or intended pregnancy
- Active suicidal ideation, anorexia, bulimia, binge eating disorder, current substance
abuse or dependence (besides nicotine dependence)
- Require assistive device for mobility or current condition that may limit or prevent
participation in moderate activity
- Use of pacemaker or other electrical implanted device
- History of bariatric (or LapBand) surgery, or considering or currently on a wait-list
for bariatric or LapBand surgery
- May not live with a current or past SMART study participant
We found this trial at
1
site
303 East Superior Street
Chicago, Illinois 60611
Chicago, Illinois 60611
Principal Investigator: Bonnie J Spring, PhD
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