Clinical trial NCT01999244: Impact of Self-Monitoring Technology and Interventionist Contact on Weight Loss
Official title: Impact of Self-Monitoring Technology and Interventionist Contact on Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Keywords: Overweight
Obesity
Weight Loss
Self-monitoring
Food Records
Self-weighing
Technology
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2013-12-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Weight
timeFrame: 6 months post randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Weight Control & Diabetes Research Center
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital
name: Kathryn M Ross, PhD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: The Miriam Hospital
name: Rena R Wing, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chhabria K, Ross KM, Sacco SJ, Leahey TM. The Assessment of Supportive Accountability in Adults Seeking Obesity Treatment: Psychometric Validation Study. J Med Internet Res. 2020 Jul 28;22(7):e17967. doi: 10.2196/17967.
citation: Ross KM, Wing RR. Impact of newer self-monitoring technology and brief phone-based intervention on weight loss: A randomized pilot study. Obesity (Silver Spring). 2016 Aug;24(8):1653-9. doi: 10.1002/oby.21536. Epub 2016 Jul 1.