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

Obesity Clinical Trial

Official title:

Does Early Intervention Improve Weight Loss Outcomes Among Individuals Enrolled in an Internet-based Weight Loss Program?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02163252
• Other study ID #: 211699_5
• Status: Completed
• Phase: N/A
• First received: June 10, 2014
• Last updated: February 18, 2015
• Start date: February 2014
• Est. completion date: July 2014

Study information

• Verified date: February 2015
• Source: The Miriam Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Behavioral:
• Standard

• Early Intervention

Locations

Country	Name	City	State
United States	The Miriam Hospital's Weight Control and Diabetes Research Center	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
The Miriam Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in weight		12-week	No
Secondary	frequency of self-monitoring	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.	12 weeks	No
Secondary	exercise minutes	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.	12 weeks	No