Using a State-wide Initiative to Disseminate Effective Behavioral Weight Loss Strategies: Study 5

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: Standard; Behavioral: Early Intervention

• Registration Number: NCT02163252
• Lead Sponsor: The Miriam Hospital

Brief Summary

The purpose of this study is to examine whether providing additional intervention support to individuals with lower than expected weight loss within the initial stages of an internet-based behavioral weight loss program improves weight loss outcomes at Week 12, compared to the internet program alone.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-06-10
• Study First Submitted QC: 2014-06-11
• Study First Posted: 2014-06-13
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-18
• Last Update Posted: 2015-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• age 18-70 years
• BMI >=25 kg/m2
• No health problems that make weight loss or unsupervised exercise unsafe
• English speaking
• Access to computer/internet

Exclusion Criteria

• report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire 62 (PAR-Q; items 1-4).
• Individuals endorsing joint problems, prescription medication use or other medical conditions that could limit exercise will be required to obtain written consent to participate from a health care provider
• are currently pregnant or intend to become pregnant in the next 12 months
• are planning to move outside of the state within the next 4 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard	Standard	A 12-week internet-based weight loss program that involves weekly video lessons, a self-monitoring platform where participants submit their weight, calorie, and activity information, and weekly automated feedback.
Early intervention	Early Intervention	Participants randomized to Early Intervention will receive the same internet-based weight loss program compared to the Standard group. In addition, Early Intervention participants achieving less than optimal weight loss following several weeks of treatment will be given the opportunity to come to the Weight Control and Diabetes Research Center for an individual visit. At this visit, an interventionist will discuss with the participant any barriers that he or she may be experiencing and recommend alternate strategies to assist in their weight loss. One such strategy would be to recommend the use of meal replacement products or portion controlled meals. In addition to this one-time visit, the interventionist will follow up with the participant via phone weekly, for 2 weeks following this in-person visit.

Primary Outcome Measures

Name	Time	Method
Change in weight	12-week

Secondary Outcome Measures

Name	Time	Method
frequency of self-monitoring	12 weeks	A secondary aim is to examine whether the provision of additional intervention support improves the frequency of self-monitoring as measured by the number of days that an individual logged their calorie information on the study website.
exercise minutes	12 weeks	A secondary aim is to examine whether the provision of additional intervention support improves the number of exercise minutes reported each week, as logged by the individual on the study website.

Trial Locations

Locations (1)

The Miriam Hospital's Weight Control and Diabetes Research Center; 🇺🇸 Providence, Rhode Island, United States