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The Comparison of a Technology-Based System and an In-Person Behavioral Weight Loss Intervention

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John M. Jakicic, PhD, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01134874
First received: May 25, 2010
Last updated: June 12, 2012
Last verified: June 2012
  Purpose

The primary aim of this study is to compare the changes in body weight between a technology-based system, an in-person behavioral weight loss intervention, and a combination of both during a 12 month behavioral weight loss intervention in adults. Sedentary, healthy overweight and obese adults will be recruited to participate. Assessments will be conducted at 0, 6, and 12 months. This is a randomized trial in which participants will be randomized to one of three groups: standard behavioral weight loss (SBWL), standard behavioral weight loss plus technology (SBWL+TECH), and technology alone alone (TECH).


Condition Intervention Phase
Obesity
Behavioral: Standard weight loss intervention
Behavioral: Standard weight loss intervention plus technology
Behavioral: Technology only
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Comparison of a Technology-Based System and an In-Person Behavioral Weight Loss Intervention

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • weight [ Time Frame: change from 0 to 6 months ] [ Designated as safety issue: No ]
    Body weight will be assessed on a digital scale to assess change in body weight over the intervention period.


Secondary Outcome Measures:
  • cardiorespiratory fitness [ Time Frame: 0, 6, 12, months ] [ Designated as safety issue: No ]
    A graded exercise test on a treadmill along with indirect calorimetry will be used to measure cardiorespiratory fitness. This will provide a measure of oxygen consumption and metabolic equivalents of work at the time of test termination.

  • body composition [ Time Frame: 0, 6, 12 months ] [ Designated as safety issue: No ]
    Body composition will be assessed using dual energy X-ray absorptiometry (DXA). This will provide a measure of lean body mass, fat mass, bone mineral content, and percent body fat.

  • physical activity [ Time Frame: 0, 6, 12 months ] [ Designated as safety issue: No ]
    A questionnaire and a portable device worn on the upper arm will be used to measure and quantify energy expenditure from physical activity.

  • dietary intake [ Time Frame: 0, 6, 12 months ] [ Designated as safety issue: No ]
    A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.

  • psychosocial and behavioral measures [ Time Frame: 0, 6, 12 months ] [ Designated as safety issue: No ]
    Questionnaires will be used to assess self-efficacy for weight loss and physical activity, barriers to physical activity and weight loss, expected outcomes resulting from physical activity and weight loss, perceived body image, depressive symptomotology, weight history, dietary disinhibition and restraint, and behaviors typically related to weight loss (e.g., self-weighing, meal planning, etc.).

  • Weight change [ Time Frame: weight at 0, 6, and 12 months ] [ Designated as safety issue: No ]
    Body weight measured on a digital scale


Estimated Enrollment: 75
Study Start Date: August 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Standard weight loss intervention Behavioral: Standard weight loss intervention
In-person weight loss sessions, dietary intake prescription of 1200-1500 kcal per day, exercise progressing to 300 minutes per week.
Experimental: Standard weight loss intervention plus technology Behavioral: Standard weight loss intervention plus technology
In-person weight loss sessions, dietary intake prescription of 1200-1500 kcal per day, exercise progressing to 300 minutes per week, plus technology to provide real-time feedback on energy expenditure, plus a website to log dietary intake.
Experimental: Technology only Behavioral: Technology only
One intervention telephone call per month, dietary intake prescription of 1200-1500 kcal per day, exercise progressing to 300 minutes per week, plus technology to provide real-time feedback on energy expenditure, plus a website to log dietary intake.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ages of 21-55 years
  • Body mass index (BMI) between 25-39.9 kg/m2

Exclusion Criteria:

  • Currently pregnant, pregnant in the last 6 months, or plan on becoming pregnant in the next 6 months.
  • Currently participating in regular exercise for over 60 minutes/week.
  • Taking any medications that affect body weight or metabolism (e.g. synthroid).
  • Have any physical limitations that would prevent exercise.
  • Currently being treated for coronary heart disease, diabetes mellitus, hypertension, or cancer.
  • Have a history of myocardial infarction or other heart-related surgeries.
  • Have a resting systolic blood pressure > 150 mmHg or diastolic blood pressure of > 100 mmHg or currently taking any medications that affect blood pressure or heart rate (e.g. beta blockers).
  • Currently enrolled in a commercial weight loss program, participating in another weight loss study, or in a weight loss study in the last 12 months.
  • Have lost > 5% of current body weight in the past 6 months.
  • Currently being treated for any psychological problems or taking any psychotropic medication.
  • Currently do not have access to a computer and the Internet that can be used for this study. This requires a PC computer, the ability to load software for the technology system, an existing internet connection provided by the participant, and a dedicated USB port to allow the armband from the technology system to be connected to the computer for the download of information.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01134874

Locations
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15260
Sponsors and Collaborators
John M. Jakicic, PhD
Investigators
Principal Investigator: John M. Jakicic, PhD University of Pittsburgh
Study Director: Steve Verba, MS University of Pittsburgh
  More Information

No publications provided

Responsible Party: John M. Jakicic, PhD, Professor and Chair, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01134874     History of Changes
Other Study ID Numbers: PRO09040121
Study First Received: May 25, 2010
Last Updated: June 12, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Weight Loss
Body Weight
Body Weight Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014