Obesity
Conditions
Brief summary
To test the effectiveness of interventions designed to promote long-term weight management of obese women in medically underserved rural counties.
Detailed description
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.
Interventions
BEHAVIORALFace-to-face counseling
Biweekly group behavioral counseling sessions conducted in a face-to-face format
BEHAVIORALTelephone counseling
Biweekly telephone counseling sessions conducted in a one-on-one format
OTHERMail contact
Biweekly written newsletters with weight management advice delivered via U.S. mail
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
BMI between 30 and 45
Exclusion criteria
presence of serious disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight. | one year | Change in body weight during the 12-month period following completion of a 6-month lifestyle treatment for obesity. |
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Face-to-face Counseling 26 biweekly face-to-face group counseling sessions | 83 |
| Telephone Counseling 26 biweekly telephone counseling sessions | 72 |
| Mail Contact 26 biweekly newsletters with weight management advice | 79 |
| Total | 234 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 7 | 2 | 3 |
Baseline characteristics
| Characteristic | Face-to-face Counseling | Telephone Counseling | Mail Contact | Total |
|---|---|---|---|---|
| Age, Continuous | 59.2 years STANDARD_DEVIATION 6.2 | 59.8 years STANDARD_DEVIATION 6.2 | 58.6 years STANDARD_DEVIATION 6 | 59.4 years STANDARD_DEVIATION 6.1 |
| Body weight | 97.8 kg STANDARD_DEVIATION 14.3 | 96.4 kg STANDARD_DEVIATION 16.8 | 95.0 kg STANDARD_DEVIATION 13.4 | 96.4 kg STANDARD_DEVIATION 15.6 |
| Region of Enrollment United States | 83 participants | 72 participants | 79 participants | 234 participants |
| Sex: Female, Male Female | 83 Participants | 72 Participants | 79 Participants | 234 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 19 / 83 | 9 / 72 | 12 / 79 |
| serious Total, serious adverse events | 21 / 83 | 20 / 72 | 12 / 79 |
Outcome results
Primary
Change in Body Weight.
Change in body weight during the 12-month period following completion of a 6-month lifestyle treatment for obesity.
Time frame: one year
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Face-to-face Counseling | Change in Body Weight. | 1.2 kg | Standard Error 0.6 |
| Telephone Counseling | Change in Body Weight. | 1.2 kg | Standard Error 0.7 |
| Mail Contact | Change in Body Weight. | 3.7 kg | Standard Error 0.7 |