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OpenTrials
Completed

NCT Number: NCT02688621

Internet Assisted Obesity Treatment Enhanced With Financial Incentives

The investigators propose a randomized controlled trial to evaluate whether the addition of financial incentives to a high-quality, online behavioral weight loss intervention produces better weight losses than the online treatment alone.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of South Carolina, Columbia, South Carolina, United States

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About this study

Overweight and obese but otherwise healthy participants (N=416) will be recruited in approximately equal numbers at two clinical centers, the University of South Carolina and the University of Vermont. Eligible participants will be randomized to one of two conditions: 1) an 18-month, 36-session group Internet behavioral weight control treatment (Internet Only) which replicates the intervention the investigators have implemented previously; or 2) the same 18-month, 36-session group Internet treatment plus financial incentives for performance of 3 key self-management behaviors (Internet+ Incentive). Both conditions will have access to the same web-based intervention platform and the same counselor-delivered intervention elements; the presence of economic incentives for behavioral and weight goals is the only difference between the conditions. Assessments will be conducted at Baseline, 2, 6, 12 and 18 months. Cost data will be collected to inform cost effectiveness evaluations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • over 18
  • BMI between 25 and 50
  • Not currently pregnant or pregnant in the previous 6 months and currently breastfeeding or planning on becoming pregnant in 18 months
  • Have a computer at home or at work with flashplayer, access to the internet, and a smart phone (to allow use of step counting aps)
  • Free of medical problems that might contraindicate participation in a behavioral weight reduction program containing an exercise component
  • Not enrolled in another weight reduction program
  • Not currently on medication that would affect weight loss

Exclusion criteria

  • had a heart attack or stroke in the previous six months
  • had weight loss surgery
  • lost 10 pounds or more in the previous 6 months
  • currently taking medications for weight loss
  • required by their doctor to follow a special diet (other than low fat)
  • planning to move out of the area within 18 months
  • schedule conflicts making it difficult to attend online "chats"
  • live more than 60 minutes driving distance from either University of South Carolina or University of Vermont campuses

Treatment and study plan

Internet Only

Behavioral

18 month behavioral weight loss intervention delivered online

Internet + Incentives

Behavioral

18 month behavioral weight loss intervention delivered online with the possibility of earning incentives for losing weight and performing weight loss behaviors including monitoring food intake, exercising, and daily weighing

Primary outcomes

  1. Weight Change

    Time frame: 6 months

    Weight will be measured at baseline, 2, 6 months. Weight loss at 6 months will be calculated as kg lost from baseline.

Secondary outcomes

  1. Class Attendance

    Time frame: 6 months

    Average number of classes attended

  2. Self Monitoring of Body Weight

    Time frame: 6 months

    Number of days with body weight self reported

  3. Dietary Intake Self Monitoring

    Time frame: 6 months

    Number of days reported dietary intake over 6 months

  4. Self Monitoring of Physical Activity

    Time frame: 6 months

    Number of days physical activity reported

  5. Steps/Day

    Time frame: 6 months

    Number of Steps/day

Sponsors and collaborators

Lead sponsor

University of Vermont

Other

Collaborators

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

Registry information

Acronym: iREACH3

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Feb 23, 2016
Registry last updated
Oct 29, 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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