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Completed

NCT Number: NCT01134874

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

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).

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard weight loss intervention

Behavioral

In-person weight loss sessions, dietary intake prescription of 1200-1500 kcal per day, exercise progressing to 300 minutes per week.

Standard weight loss intervention plus technology

Behavioral

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.

Technology only

Behavioral

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.

Primary outcomes

  1. weight

    Time frame: change from 0 to 6 months

    Body weight will be assessed on a digital scale to assess change in body weight over the intervention period.

Secondary outcomes

  1. cardiorespiratory fitness

    Time frame: 0, 6, 12, months

    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.

  2. body composition

    Time frame: 0, 6, 12 months

    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.

  3. physical activity

    Time frame: 0, 6, 12 months

    A questionnaire and a portable device worn on the upper arm will be used to measure and quantify energy expenditure from physical activity.

  4. dietary intake

    Time frame: 0, 6, 12 months

    A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.

  5. psychosocial and behavioral measures

    Time frame: 0, 6, 12 months

    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.).

  6. Weight change

    Time frame: weight at 0, 6, and 12 months

    Body weight measured on a digital scale

Sponsors and collaborators

Lead sponsor

John M. Jakicic, PhD

Other

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 2, 2010
Registry last updated
Aug 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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