Innovative Approaches to Diet, Exercise and Activity

Body Weight Clinical Trial

— IDEA  

Official title:

Enhanced Behavioral Intervention to Improve Long-Term Weight Loss in Young Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01131871
• Other study ID #: U01HL096770
• Status: Completed
• Phase: Phase 2
• First received: May 24, 2010
• Last updated: August 4, 2015
• Start date: September 2010
• Est. completion date: November 2014

Study information

• Verified date: August 2015
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The prevalence of obesity in young adults has been increasing, and excessive body weight have been linked to numerous chronic conditions including cardiovascular disease, diabetes, many forms of cancer, and numerous musculoskeletal problems. This study will focus of the development and evaluation of interventions that may be appropriate for young adults (age 18-35 years) to improve weight loss outcomes following a 24 month intervention. The primary aim of this study is to examine whether an enhanced weight loss intervention (EWLI) that includes technology components results in improved weight loss in young adults (18-35 years of age) compared to a standard behavioral weight loss intervention (SBWP) over a period of 24 months. Eligible participants will also be assessed for body composition, body fat distribution, fitness, physical activity, dietary intake, and behavioral/psychosocial measures that may be predictive of behavior change. Assessments will occur at 0, 6, 12, 18, and 24 months. Subjects will participate in a 24 month behavioral weight loss program that includes a reduction in energy intake and moderate-to-vigorous intensity exercise (progressively increasing from 100 to 300 minutes per week). The technologies added to EWLI are text messaging, a wearable device that provides feedback on physical activity, and access to a website to monitor dietary behaviors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 471
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• 18-35 years of age

• Intending to be available for a 24 month intervention

• An active cellular telephone that is capable of receiving text messaging

• A computer and internet connectivity that can be used for the BodyMedia Fit system

• Body mass index (BMI) between 25.0-39.9 kg/m2

• The ability to provide medical clearance to participate in this study from their primary care physician

• The ability to complete the baseline graded exercise test, and clearance from the study physician to participate in this study after reviewing the results from this study

Exclusion Criteria:

• Unable to provide informed consent

• Household member on study staff

• Past or planned (within the next 24 months) weight loss surgery (e.g. gastric bypass, lap band, or liposuction); current participation in a commercial weight loss program (e.g. Weight Watcher's, Jenny Craig); current or planned enrollment in another diet/PA/weight loss intervention study

• Report regular use of systemic steroids, prescription weight loss drugs. "Regular use" is defined as "taking this medication most days of the week for the previous month"

• Current treatment for eating disorder

• Cardiovascular event (heart attack, stroke, episode of heart failure, or revascularization procedure) within the last 6 months

• Current treatment for malignancy (other than non-melanoma skin cancer)

• Currently pregnant or gave birth within the last 6 months, currently lactating or breastfeeding within the last 3 months, actively planning pregnancy within the next 24 months

• Investigator discretion

• Currently taking medication that would affect heart rate or blood pressure responses to exercise (e.g., beta blockers)

• Report losing >5% of current body weight in the previous 6 months

• Currently treated for psychological issues, or taking psychotropic medications within the previous 6 months

• Report taking medication that could affect metabolism or change body weight

• Current treatment for diabetes mellitus

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Weight

Intervention

Behavioral:
• Standard Behavioral Weight Loss Intervention
Subjects in this group will receive our standard behavioral weight control program that is delivered in an in-person group-based format. At month 7 subjects will also be given access to a study website to monitor eating and activity behaviors, and to have electronic access to standardized intervention materials. At month 7 subjects will also receive targeted study-related text messages that otherwise would have been provided in paper format.
• Enhanced Weight Loss Intervention
Subjects in this group will participate in a weight loss intervention that includes technology enhancements. These enhancements will include the addition of intervention specific targeted and tailored text messaging and the BodyMedia Fit System® beginning at Month 7. At month 7 subjects in EWLI will also receive the same targeted study-related text messages provided to SBWP that otherwise would have been provided in paper format.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight change	Body weight will be assessed on a digital scale to assess change in body weight over the 24 month intervention period.	Change from baseline to 24 months	No
Secondary	body composition	Body composition will be assessed using DXA. This will provide a measure of lean body mass, fat mass, bone mineral content, and percent body fat.	0, 6, 12, 18 24 months	No
Secondary	cardiorespiratory fitness	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.	0, 6, 12, 18, 24 months	No
Secondary	physical activity energy expenditure	A questionnaire and a portable device worn on the upper arm will be used to measure and quantify energy expenditure from physical activity.	0, 6, 12, 18, 24 months	No
Secondary	dietary intake	A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.	0, 6, 12, 18, 24 months	No
Secondary	psychosocial and behavioral measures	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, sleep patterns, weight history, dietary disinhibition and restraint, and behaviors typically related to weight loss (e.g., self-weighing, meal planning, etc.).	0, 6, 12, 18, 24 months	No