Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01HL073326 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To test the effectiveness of interventions designed to promote long-term weight management of obese women in medically underserved rural counties.
BACKGROUND:
The recent dramatic rise in the prevalence of obesity has heightened awareness of the significant impact of overweight, physical inactivity, and unhealthy eating patterns on the development of chronic diseases and disability While there is little doubt that obesity and associated lifestyle factors (e.g., sedentary lifestyle) constitute serious threats to health, it is also clear that lifestyle interventions can produce body weight reductions of sufficient magnitude to improve health. The existing research is limited, however, with respect to two important factors, specifically, its generalizability to underserved populations, and the maintenance of treatment effects. Most weight-loss trials have consisted of efficacy studies conducted with middle-class participants and delivered in "optimal" (i.e., academic research) venues rather than in "real world" (i.e., community) settings. Furthermore, the existing literature shows that, in the absence of long-term care, a regaining of lost weight routinely follows the conclusion of treatment. Recent research has shown improved maintenance of lost weight when lifestyle interventions are supplemented with clinic-based follow-up programs. Thus, the next logical steps in this line of research are (a) to extend these studies to community settings with underserved populations and (b) to test promising alternative and potentially more efficient modes of treatment delivery, such as follow-up care via telephone-based contacts rather than via in-person clinic visits.
DESIGN NARRATIVE:
A randomized controlled clinical trial will examine the impact of two maintenance interventions designed to sustain weight lost in lifestyle treatment of obesity. The study sample will include 300 obese women, ages 50-75 years, from medically underserved rural areas in North Central Florida. All participants will receive a 6-month lifestyle intervention for weight loss (called Phase 1) followed by randomization to one of three 12-month follow-up (called Phase 2) programs: (A) a Face-to-Face Office-Based Maintenance Program, (B) a Telephone-Based Maintenance Program, or (C) an Education Comparison Condition. Participants will be stratified according to county and to BMI, and randomly assigned in groups of 11-12 to one of the two experimental programs or to the comparison condition. The experimental maintenance programs are designed to help participants sustain the eating and physical activity patterns needed to maintain lost weight. The primary difference between the two maintenance programs is their mode of delivery. One will be delivered via an office-based group counseling format; the other will be delivered via telephone counseling. The education comparison condition will involve a program of print materials on the maintenance of a healthy lifestyle delivered via biweekly newsletters.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Face-to-face counseling | Experimental | 26 biweekly face-to-face group counseling sessions |
|
| Telephone Counseling | Experimental | 26 biweekly telephone counseling sessions |
|
| Mail contact | Active Comparator | 26 biweekly newsletters with weight management advice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Face-to-face counseling | Behavioral | Biweekly group behavioral counseling sessions conducted in a face-to-face format |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight. | Change in body weight during the 12-month period following completion of a 6-month lifestyle treatment for obesity. | one year |
Not provided
Not provided
Inclusion criteria:
BMI between 30 and 45
Exclusion criteria:
presence of serious disease
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael G Perri, PhD | University of Florida | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19029500 | Result | Perri MG, Limacher MC, Durning PE, Janicke DM, Lutes LD, Bobroff LB, Dale MS, Daniels MJ, Radcliff TA, Martin AD. Extended-care programs for weight management in rural communities: the treatment of obesity in underserved rural settings (TOURS) randomized trial. Arch Intern Med. 2008 Nov 24;168(21):2347-54. doi: 10.1001/archinte.168.21.2347. |
Not provided
Not provided
298 women participated in a standard 6-month lifestyle modification program for weight loss, delivered in groups at Cooperative Extension Offices. Eligibility for randomization required completion of the 6-month lifestyle program; 234 completed the initial treatment and were assigned randomly to one of the three extended care conditions.
Study announcements were mailed to households in 6 rural counties in northern Florida designated in whole or in part as health professional shortage areas. Women who responded to the announcements were invited to an orientation/screening session wherein informed consent was obtained. Height and weight were measured by a registered nurse.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Face-to-face Counseling | 26 biweekly face-to-face group counseling sessions |
| FG001 | Telephone Counseling | 26 biweekly telephone counseling sessions |
| FG002 | Mail Contact | 26 biweekly newsletters with weight management advice |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Face-to-face Counseling | 26 biweekly face-to-face group counseling sessions |
| BG001 | Telephone Counseling | 26 biweekly telephone counseling sessions |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Body Weight. | Change in body weight during the 12-month period following completion of a 6-month lifestyle treatment for obesity. | Data from all randomized participants were analyzed according to the Intent to Treatment principle. Missing data (6%) were completed based on known pattern of weight regain (i.e., 0.3 kg per month). | Posted | Mean | Standard Error | kg | one year |
|
1 year
self-reporting by participants
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Face-to-face | received 26 biweekly office-based, face-to-face group counseling sessions |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cardiac symptom | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| minor musculoskeletal injuries | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael G. Perri, PhD | University of Florida | 352 273-6214 | mperri@ufl.edu |
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Telephone counseling | Behavioral | Biweekly telephone counseling sessions conducted in a one-on-one format |
|
| Mail contact | Other | Biweekly written newsletters with weight management advice delivered via U.S. mail |
|
| BG002 | Mail Contact | 26 biweekly newsletters with weight management advice |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body weight | Mean | Standard Deviation | kg |
|
| OG002 |
| Mail Contact |
26 biweekly newsletters with weight management advice |
|
|
| 21 |
| 83 |
| 19 |
| 83 |
| EG001 | Telephone | received 26 biweekly individual telephone counseling sessions | 20 | 72 | 9 | 72 |
| EG002 | received by mail 26 biweekly newsletters with weight management information | 12 | 79 | 12 | 79 |
| circulatory problems | Vascular disorders | Non-systematic Assessment |
|
| ear problems | Ear and labyrinth disorders | Non-systematic Assessment |
|
| eye problem | Eye disorders | Non-systematic Assessment |
|
| gynecologic and breast problems | Reproductive system and breast disorders | Non-systematic Assessment |
|
| kidney problem | Renal and urinary disorders | Non-systematic Assessment |
|
| musculoskeletal injury | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| neurological symptoms | Nervous system disorders | Non-systematic Assessment |
|
| respiratory problem | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| thyroid problem | Endocrine disorders | Non-systematic Assessment |
|
Not provided
Not provided
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |