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Completed

NCT Number: NCT02997943

SMART Weight Loss Management

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.

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Key information

Conditions

Weight Loss Behavior Body Weight Body Weight Changes Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Step 1 Treatment: APP

Behavioral

Participants will receive a smartphone app to track weight, dietary intake and physical activity, and a technology core consisting of web-based weekly lessons, wireless scale, and activity tracker. Participants will use their own smartphone to receive the study smartphone application.

Step 1 Treatment: APP + Coaching

Behavioral

Participants will receive a smartphone app to track weight, dietary intake and physical activity; a technology core consisting of web-based weekly lessons, wireless scale, and activity tracker; 12 weekly telephone coaching sessions. Participants will use their own smartphone to receive the study smartphone application.

Step 2 Treatment Strategy: Modest Step-up

Behavioral

In addition to first line treatment, participants identified as non-responders will be provided an additional mHealth intervention component (push notifications) for the remaining 12 weeks.

Step 2 Treatment Strategy: Vigorous Step-up

Behavioral

In addition to the first line treatment, participants identified as non-responders will be provided an additional mHealth intervention component (push notifications) plus a traditional weight loss intervention component (coaching, meal replacements).

Primary outcomes

  1. Change in weight at 6 months

    Time frame: baseline, 6 months

    Weight measured in the lab, taken without shoes, wearing light clothing on a calibrated beam balance scale

Other outcomes

  1. Change in weight at 12 months

    Time frame: baseline, 12 months

    Weight measured in the lab, taken without shoes, wearing light clothing on a calibrated beam balance scale

  2. Cost effectiveness

    Time frame: 12 months

    Cost/pound lost of each study sequence embedded within the SMART design.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • University of Michigan

Registry information

Acronym: SMART

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Dec 20, 2016
Registry last updated
May 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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