Tailored Lifestyle Intervention in Obese Adults Within Primary Care Practice - Choose to Lose

NCT01542671 | Completed DMC

• 2 other identifiers: 09-325R18DK079880
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study is to evaluate the effectiveness of tailored lifestyle intervention in primary care by comparing changes in the primary measure of weight and body mass index (BMI) and secondarily: physical activity (PA), fat calories consumed, and fruit/vegetable servings within the two arms (intervention and control) of the study. It is hypothesized that the intervention cohort will demonstrate greater reductions in body weight, body neglect, and fat calories consumed and greater increases in physical activity and fruits/vegetable servings after two years compared to the control cohort. The study also aims to evaluate and compare the cost of intervention for purpose per each unit of measure lost between the two arms of the study as a secondary objective. The cost of intervention will be evaluated as it relates to study replication.

Conditions

Overweight and Obesity

Keywords

lifestyle change; obesity treatment; physical activity; primary care; quality of life

Outcome Measures

Primary Outcomes (1)

• Changes in Body Weight & Physical Activity

  The primary outcomes of the trial are measured changes in BMI and physical activity level.

  Five years

Secondary Outcomes (2)

• Cost Effectiveness

  Five Years

• Eating Behaviors

  5 years

Study Arms (2)

Intervention

EXPERIMENTAL

Lifestyle counseling at baseline, six, twelve months; Food and exercise log recording and feedback, motivational phone calls monthly for 12 months, 4 tailored mailings on lifestyle change, and weekly mailings on weight loss, exercise, and healthy eating for first 12 months. Maintenance mailings biweekly for six months and then monthly during the second year.

Behavioral: Intervention

Control

PLACEBO COMPARATOR

Lifestyle counseling at baseline, six and twelve months similar to intervention group, and infrequent non-tailored pamphlets.

Behavioral: Control

Interventions

Intervention BEHAVIORAL

* Lifestyle Counselor meetings at baseline, 6 months, and 12 months * Structured eating plan * Tailored nutritional and exercise tips. Weekly: months 1-12, biweekly: months 13-18, and monthly: months 19-24. * Monthly Motivational phone calls with Lifestyle Counselor for the first year * 4 informational DVDs over the two year period * Feedback on submitted food and exercise journals

Intervention

Control BEHAVIORAL

* Lifestyle Counselor meetings at baseline, 6 months, and 12 months * Structured eating plan * 5 informational NIDDK mailings over the two year period

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male/female ≥18 and \<80 years old
• Available for this research project for the entire 24-month study period
• Able to read and speak English
• Can provide informed consent

You may not qualify if:

• Diagnosed or hospitalization for active CVD disease in the past 6 months including: CHD or history of coronary revascularization procedure (e.g. angioplasty, bypass graft surgery), Stroke, Peripheral Vascular Disease, Heart Failure, Deep Vein Thrombosis (DVT)
• Unstable psychiatric condition
• History of a significant orthopedic limitation or other conditions that make exercise dangerous or extremely difficult
• Limited physical activity by a physician to less than a brisk walk
• Another family member in the study
• Limited prescribed diet (e.g. gluten free diet)
• Present treatment for an eating disorder
• Underwent treatment for cancer in the past 5 years
• Dialysis
• Poorly controlled diabetes (HgbA1c \> 10) or hospitalized in past 6 months for poorly controlled diabetes
• Chronic steroid therapy
• Participant requesting surgical treatment of obesity or weighing over 400 lbs.
• Major surgery in the past month
• Participating in another clinical trial with regards to obesity or physical activity

Sponsors & Collaborators

• Memorial Hospital of Rhode Island: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Memorial Hospital of Rhode Island

Pawtucket, Rhode Island, 02816', United States

Location

MeSH Terms

Conditions

Overweight; Obesity; Motor Activity

Interventions

Methods

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Charles B Eaton, MD

  Memorial Hospital of Rhode Island

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 27, 2012
• First Posted: March 2, 2012
• Study Start: September 1, 2009
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2015
• Last Updated: April 4, 2016

Record last verified: 2016-03

Locations

US (1)