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Evaluation of a Health at Every Size vs a Behavioral Weight Loss Approach for Obese Women

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by The Reading Hospital and Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
The Edna G. Kynett Memorial Foundation
Information provided by:
The Reading Hospital and Medical Center
ClinicalTrials.gov Identifier:
NCT00769717
First received: October 8, 2008
Last updated: August 26, 2009
Last verified: August 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Obesity
 Behavioral: Wellness-Centered (HUGS)
Behavioral: Weight-Centered (LEARN)
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparative Health Improvements and Rate of Relapse in Weight-Centered vs. Wellness-Centered Interventions for Obese Women

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Reading Hospital and Medical Center:

Primary Outcome Measures:
  • Systolic and Diastolic Blood Pressure [ Time Frame: Baseline, post-intervention, 6-months post intervention, 12-months post intervention, 18-months post intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Fasting Blood Glucose [ Time Frame: baseline, post intervention, 6-months post intervention, 12-months post intervention, 18-months post intervention ] [ Designated as safety issue: No ]
  • self-esteem [ Time Frame: baseline, post intervention, 6-months post intervention, 12-months post intervention, 18-months post intervention ] [ Designated as safety issue: No ]
  • depressed mood [ Time Frame: baseline, post intervention, 6-months post intervention, 12-months post intervention, 18-months post intervention ] [ Designated as safety issue: No ]
  • anxiety [ Time Frame: baseline, post intervention, 6-months post intervention, 12-months post intervention, 18-months post intervention ] [ Designated as safety issue: No ]
  • stress [ Time Frame: baseline, post intervention, 6-months post intervention, 12-months post intervention, 18-months post intervention ] [ Designated as safety issue: No ]
  • eating, weight, and body shape attitudes [ Time Frame: baseline, post intervention, 6-months post intervention, 12-months post intervention, 18-months post intervention ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: baseline, post intervention, 6-months post intervention, 12-months post intervention, 18-months post intervention ] [ Designated as safety issue: No ]
  • physical activity [ Time Frame: baseline, post intervention, 6-months post intervention, 12-months post intervention, 18-months post intervention ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • dietary habits [ Time Frame: baseline, post intervention, 6-months post intervention, 12-months post intervention, 18-months post intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: October 2008
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Wellness-Centered
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.
 Behavioral: Wellness-Centered (HUGS)
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.
Other Names:
  • Health At Every Size
  • Intuitive Eating
Active Comparator: Weight-Centered
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.
 Behavioral: Weight-Centered (LEARN)
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.
Other Name: behavior based weight loss program

  Eligibility

Ages Eligible for Study:   30 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00769717

Locations
United States, Pennsylvania
The Reading Hospital and Medical Center
West Reading, Pennsylvania, United States, 19611
Sponsors and Collaborators
The Reading Hospital and Medical Center
The Edna G. Kynett Memorial Foundation
Investigators
Principal Investigator: Janell L Mensinger, Ph.D. The Reading Hospital and Medical Center
Principal Investigator: James Ku, MD The Reading Hospital and Medical Center
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Janell Mensinger, Ph.D., Sr. Research Associate, The Reading Hospital and Medical Center
ClinicalTrials.gov Identifier: NCT00769717     History of Changes
Other Study ID Numbers: TRHMC 02708
Study First Received: October 8, 2008
Last Updated: August 26, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by The Reading Hospital and Medical Center:
obesity
wellness
cardiovascular disease prevention
health at every size
weight loss

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013