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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

Tracking Information
First Submitted Date  ICMJE June 10, 2014
First Posted Date  ICMJE June 13, 2014
Last Update Posted Date February 19, 2015
Study Start Date  ICMJE February 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2014)
Change in weight [ Time Frame: 12-week ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2014)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Using a State-wide Initiative to Disseminate Effective Behavioral Weight Loss Strategies: Study 5
Official Title  ICMJE Does Early Intervention Improve Weight Loss Outcomes Among Individuals Enrolled in an Internet-based Weight Loss Program?
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • Behavioral: Standard
  • Behavioral: Early Intervention
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: Behavioral: Early Intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 11, 2014)
110
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02163252
Other Study ID Numbers  ICMJE 211699_5
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jessica Unick, The Miriam Hospital
Study Sponsor  ICMJE The Miriam Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The Miriam Hospital
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP