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

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self-monitoring skills
Technology
Interventionist Contact
Sponsored by
The Miriam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring Overweight, Obesity, Weight Loss, Self-monitoring, Food Records, Self-weighing, Technology

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Weight Control & Diabetes Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

SC

TECH

TECH+INT

Arm Description

Self-guided self-monitoring condition. Participants will receive standard self-monitoring tools and information on weight regulation.

Technology condition. Participants will receive self-monitoring technology and information regarding weight regulation.

Technology plus interventionist contact arm. Participants will receive self-monitoring technology, information regarding weight regulation, and interventionist contact via telephone.

Outcomes

Primary Outcome Measures

Weight

Secondary Outcome Measures

Full Information

First Posted
November 25, 2013
Last Updated
September 21, 2015
Sponsor
The Miriam Hospital
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT01999244
Brief Title
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

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Miriam Hospital
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Overweight, Obesity, Weight Loss, Self-monitoring, Food Records, Self-weighing, Technology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SC
Arm Type
Experimental
Arm Description
Self-guided self-monitoring condition. Participants will receive standard self-monitoring tools and information on weight regulation.
Arm Title
TECH
Arm Type
Experimental
Arm Description
Technology condition. Participants will receive self-monitoring technology and information regarding weight regulation.
Arm Title
TECH+INT
Arm Type
Experimental
Arm Description
Technology plus interventionist contact arm. Participants will receive self-monitoring technology, information regarding weight regulation, and interventionist contact via telephone.
Intervention Type
Behavioral
Intervention Name(s)
Self-monitoring skills
Intervention Type
Behavioral
Intervention Name(s)
Technology
Intervention Type
Behavioral
Intervention Name(s)
Interventionist Contact
Primary Outcome Measure Information:
Title
Weight
Time Frame
6 months post randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathryn M Ross, PhD MPH
Organizational Affiliation
The Miriam Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rena R Wing, PhD
Organizational Affiliation
The Miriam Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weight Control & Diabetes Research Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32720911
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.
Results Reference
derived
PubMed Identifier
27367614
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.
Results Reference
derived

Learn more about this trial

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

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