NCT01537796

Brief Summary

The purpose of this study is to examine the effect of an enhanced technology-based system, that involves a wearable device to measure calories burned combined with a website, in comparison to previous versions of similar technology and a standard behavioral weight loss on body weight across 6 months in obese adults.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 23, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

August 5, 2015

Status Verified

August 1, 2015

Enrollment Period

1.4 years

First QC Date

February 15, 2012

Last Update Submit

August 4, 2015

Conditions

Obesity

Keywords

ObesityExercise

Outcome Measures

Primary Outcomes (1)

  • Change in body weight

    Baseline, 3 months, and 6 months

Secondary Outcomes (5)

  • Change in body composition

    Baseline, 3 months, and 6 months

  • Change in moderate-to-vigorous intensity physical activity

    Baseline, 3 months, and 6 months

  • Change in dietary intake

    Baseline, 3 months, and 6 months

  • Completion of self-monitoring of eating behavior

    Baseline to 6 months

  • Frequency of self-monitoring of physical activity behavior

    Baseline to 6 months

Study Arms (3)

In-Person weight loss

EXPERIMENTAL

Participants will attend weekly group intervention meetings. These sessions will address barriers associated with altering physical activity participation and dietary intake. Group discussions will be facilitated by the interventionist and interactive participation will be encouraged. Participants will be provided with written materials at each meeting to supplement group discussions. Paper diaries will be provided each week to assist participants with self-monitoring of calorie and fat consumption, and physical activity minutes and intensity. Participants will return the diary to the intervention staff each week for review and constructive feedback.

Behavioral: In-Person weight loss

FIT weight loss

EXPERIMENTAL

Intervention materials will be provided and mailed weekly to participants. Participants will be provided with the BodyMedia® FIT System that includes a wearable device to monitor physical activity and energy expenditure, a display device to provide feedback on achievement of energy expenditure and physical activity goals, and web-based software to assist with self-monitoring of dietary intake and to provide feedback on goal achievement. Participants will attend one introductory session in which a tutorial of the components of the enhanced FIT System will be provided. Participants will receive a one-hour lesson on basic guidelines of the weight loss intervention. Once per month participants will receive a scheduled 10 minute intervention telephone call with the intervention staff.

Behavioral: FIT weight loss

FIT-BT weight loss

EXPERIMENTAL

Participants will be provided with intervention materials that are mailed weekly to them. Participants will be provided with the enhanced BodyMedia® FIT System that includes a wearable device with Bluetooth® technology to allow participants to receive real-time feedback on calories expended and physical activity on their smart phone. This also supports self-monitoring of dietary behaviors and body weight. Participants will attend one introductory session in which a tutorial of the components of the enhanced FIT System will be provided. Participants will also receive a one-hour lesson on basic guidelines of the weight loss intervention. Once per month participants will receive a scheduled 10 minute intervention telephone call with the intervention staff.

Behavioral: FIT-BT weight loss

Interventions

In-Person weight lossBEHAVIORAL

Participants will attend weekly group intervention meetings. These sessions will address barriers associated with altering physical activity participation and dietary intake. Group discussions will be facilitated by the interventionist and interactive participation will be encouraged. Participants will be provided with written materials at each meeting to supplement group discussions. Paper diaries will be provided each week to assist participants with self-monitoring of calorie and fat consumption, and physical activity minutes and intensity. Participants will return the diary to the intervention staff each week for review and constructive feedback.

In-Person weight loss
FIT weight lossBEHAVIORAL

Intervention materials will be provided and mailed weekly to participants. Participants will be provided with the BodyMedia® FIT System that includes a wearable device to monitor physical activity and energy expenditure, a display device to provide feedback on achievement of energy expenditure and physical activity goals, and web-based software to assist with self-monitoring of dietary intake and to provide feedback on goal achievement. Participants will attend one introductory session in which a tutorial of the components of the enhanced FIT System will be provided. Participants will receive a one-hour lesson on basic guidelines of the weight loss intervention. Once per month participants will receive a scheduled 10 minute intervention telephone call with the intervention staff.

FIT weight loss
FIT-BT weight lossBEHAVIORAL

Participants will be provided with intervention materials that are mailed weekly to them. Participants will be provided with the enhanced BodyMedia® FIT System that includes a wearable device with Bluetooth® technology to allow participants to receive real-time feedback on calories expended and physical activity on their smart phone. This also supports self-monitoring of dietary behaviors and body weight. Participants will attend one introductory session in which a tutorial of the components of the enhanced FIT System will be provided. Participants will also receive a one-hour lesson on basic guidelines of the weight loss intervention. Once per month participants will receive a scheduled 10 minute intervention telephone call with the intervention staff.

FIT-BT weight loss

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years of age
  • Body mass index (BMI) between 35.0-45.0 kg/m2

You may not qualify if:

  • Reports not having access to a computer, access to the Internet, or the availability to download software onto a computer.
  • Reports not having a smart phone device that is compatible with the BodyMedia® FIT Bluetooth® System that will be examined in this study.
  • Has a physical limitation that would prevent engaging in physical activity.
  • Participates in structured aerobic exercise for ≥ 60 minutes per week over the prior ≥ 3 months.
  • Reports being treated for a current medical condition that could affect body weight. These may include the following: cancer; diabetes mellitus; hyperthyroidism; inadequately controlled hypothyroidism; chronic renal insufficiency; chronic liver disease; gastrointestinal disorders including ulcerative colitis, Crohn's disease, or malabsorption syndromes, etc.
  • Reports current congestive heart failure, angina, uncontrolled arrhythmia, symptoms indicative of increase risk of an acute cardiovascular event, coronary artery bypass grafting or angioplasty, prior myocardial infarction, and conditions requiring anticoagulation therapy (i.e. deep vein thrombosis).
  • Has a resting systolic blood pressure ≥ 150 mmHg or resting diastolic blood pressure of ≥ 100 mmHg or taking medications to control blood pressure.
  • Being treated for any psychological issues (i.e., depression, bipolar disorder, etc) or taking psychotropic medications within the previous 12 months.
  • Taking prescription or over-the-counter medications that affect body weight and metabolism.
  • Has lost \> 5% of current body weight in the past 3 months and maintained this weight loss at the time of recruitment for this study.
  • Currently participating in an exercise or weight control study, had participated in an exercise or weight control study within the previous 6 months, or a current participant in a commercial weight reduction program.
  • Has undergone bariatric surgery (e.g., gastric bypass, lap-band) for weight loss.
  • Currently being treated for an eating disorder.
  • Currently pregnant, pregnant in the last 6 months, breast feeding in the last 3 months, lactating, to planning on becoming pregnant in the next 3 months.
  • Planning on relocating outside of the greater Pittsburgh area within the next 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

MeSH Terms

Conditions

ObesityMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • John M Jakicic, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

  • Renee J Rogers, MS

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 15, 2012

First Posted

February 23, 2012

Study Start

February 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

August 5, 2015

Record last verified: 2015-08

Locations

US(1)