Impact of Self-Monitoring Technology and Interventionist Contact on Weight Loss

Obesity Clinical Trial

Official title:

Impact of Self-Monitoring Technology and Interventionist Contact on Weight Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01999244
• Other study ID #: 209313
• Secondary ID: F32DK100069-01
• Status: Completed
• Phase: N/A
• First received: November 25, 2013
• Last updated: September 21, 2015
• Start date: December 2013
• Est. completion date: June 2015

Study information

• Verified date: September 2015
• Source: The Miriam Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Despite continued research on effective interventions, obesity remains a major public health issue in the United States. Current treatments, including behavioral weight management programs, weight loss surgery, and pharmacotherapy, tend to be high in cost and have limited reach, reducing the ability of these treatments to address the population-wide scope of the obesity epidemic. Recent advances in technology that improve the ease of self-monitoring and provide targeted feedback offer promise to help larger groups of individuals to lose weight. Despite the commercial popularity of these products, however, little research has been conducted to evaluate their impact on excess body weight or to determine how they should ideally be implemented. Two key questions need to be addressed. First, is use of self-monitoring technology sufficient to produce weight loss, or must this technology be combined with interventionist contact? Second, how cost-effective is a technology-based intervention, with and without interventionist contact? The current study is small prospective, randomized pilot study comparing a self-guided self-monitoring condition (SC) to a technology only condition (TECH) and a technology plus interventionist support condition (TECH+INT). All participants will all be given basic weight management information knowledge and randomized to one of three conditions. Participants in the self-guided self-monitoring condition (SC) will receive traditional paper self-monitoring logs, a standard body weight scale, and a pedometer and calorie book; participants in the technology-based condition (TECH) will receive an electronic activity monitor and WiFi-enabled body weight scale, and will track caloric intake via an associated website; and participants in the interventionist contact condition (TECH+INT) will receive the same technology as in the TECH condition, combined with weekly interventionist contact delivered via telephone. We will compare the impact of each condition on weight loss and investigate preliminary cost-effectiveness.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age between 18 and 70

• BMI between 27 and 40 kg/m2

• Access to a computer and WIFI in the home

Exclusion Criteria:

• Weight over 340 lbs

• Physical limitations that prevent walking 1/4 mile without stopping

• Currently participating in another weight loss program or taking weight loss medication

• Currently pregnant, lactating, less than 6-months post-partum, or plans to become pregnant during the 6-month study period

• Uncontrolled hypertension or diabetes

• History of coronary heart disease

• Terminal Illness

• Plans to relocate during the 6-month study period

• Substance Abuse

• Severe psychiatric disorders

• Dementia

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight
• Weight Loss

Intervention

Behavioral:
• Self-monitoring skills

• Technology

• Interventionist Contact

Locations

Country	Name	City	State
United States	Weight Control & Diabetes Research Center	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
The Miriam Hospital	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight		6 months post randomization	No