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

Study Overview
=================
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.

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

Conditions
-----------------
Overweight, Obesity

Intervention / Treatment
-----------------
* Behavioral: Self-monitoring skills
* Behavioral: Technology
* Behavioral: Interventionist Contact


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SC<br>Self-guided self-monitoring condition. Participants will receive standard self-monitoring tools and information on weight regulation. | Behavioral: Self-monitoring skills<br> <br> |
| Experimental: TECH<br>Technology condition. Participants will receive self-monitoring technology and information regarding weight regulation. | Behavioral: Self-monitoring skills<br> <br> Behavioral: Technology<br> <br> |
| Experimental: TECH+INT<br>Technology plus interventionist contact arm. Participants will receive self-monitoring technology, information regarding weight regulation, and interventionist contact via telephone. | Behavioral: Self-monitoring skills<br> <br> Behavioral: Technology<br> <br> Behavioral: Interventionist Contact<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight |  | 6 months post randomization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Overweight, Obesity, Weight Loss, Self-monitoring, Food Records, Self-weighing, Technology