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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02163252
Recruitment Status : Completed
First Posted : June 13, 2014
Last Update Posted : February 19, 2015
Sponsor:
Information provided by (Responsible Party):
Jessica Unick, 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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Standard Behavioral: Early Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Does Early Intervention Improve Weight Loss Outcomes Among Individuals Enrolled in an Internet-based Weight Loss Program?
Study Start Date : February 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Behavioral: Standard
Experimental: 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.
Behavioral: Early Intervention



Primary Outcome Measures :
  1. Change in weight [ Time Frame: 12-week ]

Secondary Outcome Measures :
  1. frequency of self-monitoring [ Time Frame: 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.

  2. exercise minutes [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02163252


Locations
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United States, Rhode Island
The Miriam Hospital's Weight Control and Diabetes Research Center
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
The Miriam Hospital
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Responsible Party: Jessica Unick, Assistant Professor (Research), The Miriam Hospital
ClinicalTrials.gov Identifier: NCT02163252    
Other Study ID Numbers: 211699_5
First Posted: June 13, 2014    Key Record Dates
Last Update Posted: February 19, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight