Overview

This trial is active, not recruiting.

Condition obesity
Treatments wellness-centered (hugs), weight-centered (learn)
Phase phase 2/phase 3
Sponsor The Reading Hospital and Medical Center
Collaborator The Edna G. Kynett Memorial Foundation
Start date October 2008
End date May 2011
Trial size 80 participants
Trial identifier NCT00769717, TRHMC 02708

Summary

For over four decades the medical literature has observed a relationship between obesity and poorer health outcomes. The causal mechanisms of these poorer outcomes however are unclear. One assumption that has been supported by correlational data is that increased weight is associated with increased cardiovascular disease (CVD) risk factors (i.e., hypertension, dyslipidemia, and type 2 diabetes). Consequently, obese people are routinely prescribed weight loss programs in order to prevent or control these conditions. Unfortunately, long term weight loss has been met with minimal success for the large majority of people. Furthermore, the data suggesting that weight loss leads to long term health benefits and decreased mortality is limited and contradictory. The purpose of the proposed project is to perform a randomized controlled pilot study comparing the effectiveness of two lifestyle interventions for preventing CVD risk factors (hypertension, dyslipidemia, and type 2 diabetes). The interventions are constitutionally similar; however, the treatment condition is a wellness-focused intervention that teaches healthy living without consideration of weight. The control condition is a traditional curriculum where the prescribed outcome is weight loss. The primary goals of both programs are to reduce hypertension and total cholesterol, and to enhance glucose control. Secondary outcomes of interest are psychological and behavioral in nature (e.g., self-esteem; depressed mood; anxiety; stress; quality of life; dietary habits; and physical activity). We will compare the trajectories of the CVD and psychological/behavioral risk factors for a total period of 24 months (including the time from baseline to the end of the 6-month intervention). Our objectives are to collect data to a) determine whether participants in both programs reduce CVD and psychological/behavioral risk factors at the completion of the 6-month program, and b) compare the persistency of health improvements and rate of relapse at the end of the 18-month follow-up period between the traditional weight loss intervention and the wellness-focused intervention.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
A health at every size intervention, the HUGS program was conceived and developed in 1987 by Linda Omichinski, Registered Dietitian. HUGS stands for Health focused, Understanding lifestyle, Group supported, and Self-esteem building. It is an integrated approach that promotes healthy eating, active living, and self acceptance regardless of weight. HUGS teaches strategies to recognize and respond to physiological signs of hunger and satiety to determine food intake. The manualized curriculum is accompanied by the books Tailoring Your Tastes and Staying Off of the Diet Roller Coaster which participants will receive in addition to a booklet of handouts. Kelly Bliss, a psychotherapist and fitness professional with 17 years experience in health-centered approaches for weight management, will deliver the intervention in 2 groups of 20 people that meet weekly for 6 months.
wellness-centered (hugs) Health At Every Size
A health at every size intervention, the HUGS program was conceived and developed in 1987 by Linda Omichinski, Registered Dietitian. HUGS stands for Health focused, Understanding lifestyle, Group supported, and Self-esteem building. It is an integrated approach that promotes healthy eating, active living, and self acceptance regardless of weight. HUGS teaches strategies to recognize and respond to physiological signs of hunger and satiety to determine food intake. The manualized curriculum is accompanied by the books Tailoring Your Tastes and Staying Off of the Diet Roller Coaster which participants will receive in addition to a booklet of handouts. Kelly Bliss, a psychotherapist and fitness professional with 17 years experience in health-centered approaches for weight management, will deliver the intervention in 2 groups of 20 people that meet weekly for 6 months.
(Active Comparator)
The LEARN Program for Weight Management is an evidence-based behavior modification approach to weight loss developed by Dr. Kelly Brownell, Ph.D. Psychologist. LEARN is an acronym that stands for Lifestyle, Exercise, Attitudes, Relationships, and Nutrition. This manualized curriculum shares many principals with the HUGS program in that both emphasize the importance of healthy lifestyle choices and gradual sustainable change. However, the LEARN program makes weight loss an explicit goal and focuses more on food intake levels based on external prescriptions and caloric restriction. Participants in the LEARN program will receive the LEARN Program for Weight Management manual and the LEARN Weight Stabilization and Maintenance Guide along with the LEARN Program CD set. Ann Wellock, a Registered Dietician from The Reading Hospital and Medical Center will deliver the intervention in 2 groups of 20 people that meet weekly for 6 months.
weight-centered (learn) behavior based weight loss program
The LEARN Program for Weight Management is an evidence-based behavior modification approach to weight loss developed by Dr. Kelly Brownell, Ph.D. Psychologist. LEARN is an acronym that stands for Lifestyle, Exercise, Attitudes, Relationships, and Nutrition. This manualized curriculum shares many principals with the HUGS program in that both emphasize the importance of healthy lifestyle choices and gradual sustainable change. However, the LEARN program makes weight loss an explicit goal and focuses more on food intake levels based on external prescriptions and caloric restriction. Participants in the LEARN program will receive the LEARN Program for Weight Management manual and the LEARN Weight Stabilization and Maintenance Guide along with the LEARN Program CD set. Ann Wellock, a Registered Dietician from The Reading Hospital and Medical Center will deliver the intervention in 2 groups of 20 people that meet weekly for 6 months.

Primary Outcomes

Measure
Systolic and Diastolic Blood Pressure
time frame: Baseline, post-intervention, 6-months post intervention, 12-months post intervention, 18-months post intervention

Secondary Outcomes

Measure
Blood Lipids (HDL cholesterol, LDL cholesterol, triglycerides, and total cholesterol)
time frame: baseline, post intervention, 6-months post intervention, 12-months post intervention, 18-months post intervention
Fasting Blood Glucose
time frame: baseline, post intervention, 6-months post intervention, 12-months post intervention, 18-months post intervention
self-esteem
time frame: baseline, post intervention, 6-months post intervention, 12-months post intervention, 18-months post intervention
depressed mood
time frame: baseline, post intervention, 6-months post intervention, 12-months post intervention, 18-months post intervention
anxiety
time frame: baseline, post intervention, 6-months post intervention, 12-months post intervention, 18-months post intervention
stress
time frame: baseline, post intervention, 6-months post intervention, 12-months post intervention, 18-months post intervention
eating, weight, and body shape attitudes
time frame: baseline, post intervention, 6-months post intervention, 12-months post intervention, 18-months post intervention
quality of life
time frame: baseline, post intervention, 6-months post intervention, 12-months post intervention, 18-months post intervention
physical activity
time frame: baseline, post intervention, 6-months post intervention, 12-months post intervention, 18-months post intervention
eating behavior (emotional eating, cognitive restraint, uncontrolled eating, intuitive eating)
time frame: baseline, post intervention, 6-months post intervention, 12-months post intervention, 18-months post intervention
power of food (the extent to which food controls one's life)
time frame: baseline, post intervention, 6-months post intervention, 12-months post intervention, 18-months post intervention
dietary habits
time frame: baseline, post intervention, 6-months post intervention, 12-months post intervention, 18-months post intervention

Eligibility Criteria

Female participants from 30 years up to 45 years old.

Inclusion Criteria: 1. Women ages 30 to 45 years old (at intervention onset); 2. BMI between 30 and 45 3. Physically inactive 4. Practicing birth control if heterosexually active and pre-menopausal. 5. English speaking Exclusion Criteria: 1. Current smoker 2. Use of medications known to affect weight/energy expenditure; 3. Pregnant, intending to get pregnant over next two years, or lactating; 4. Recent myocardial infarction (within 6 months); 5. Congestive heart failure 6. Active neoplasms 7. Type 1 and insulin-dependent Type 2 diabetes 8. Cerebrovascular disease 9. Renal disease 10. Cirrhosis 11. Bulimia nervosa 12. Alcohol and/or Substance Abuse 13. Major psychiatric disturbance (suicidality, psychosis, anti-social personality disorder, current manic episode) 14. Prior bariatric surgery 15. Plans to have bariatric surgery over next 2.5 years

Additional Information

Official title Comparative Health Improvements and Rate of Relapse in Weight-Centered vs. Wellness-Centered Interventions for Obese Women
Principal investigator Janell L Mensinger, Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in August 2009.
Information provided to ClinicalTrials.gov by The Reading Hospital and Medical Center.