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

NCT ID: NCT02163252

Last Updated: 2015-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2014-07-31

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Standard

Intervention Type: BEHAVIORAL

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.

Group Type: EXPERIMENTAL

Early Intervention

Intervention Type: BEHAVIORAL

Interventions

Standard

Intervention Type: BEHAVIORAL

Early Intervention

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Miriam Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jessica Unick

Assistant Professor (Research)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Miriam Hospital's Weight Control and Diabetes Research Center

Providence, Rhode Island, United States

Countries

United States

Other Identifiers

211699_5

Identifier Type: -

Identifier Source: org_study_id