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

Study Overview
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Brief Summary
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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.

Official Title
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Comparative Health Improvements and Rate of Relapse in Weight-Centered vs. Wellness-Centered Interventions for Obese Women

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Wellness-Centered (HUGS)
* Behavioral: Weight-Centered (LEARN)


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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1:1 Parallel assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wellness-Centered<br>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)<br>* 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.<br>* Other names: Intuitive Eating;|
| Active Comparator: Weight-Centered<br>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)<br>* 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.<br>* Other names: behavior based weight loss program;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Lipids | LDL, HDL, Total Cholesterol, Triglycerides (mg/dL) | Baseline, post-intervention, 18-24 months post intervention | 
| Blood Pressure | Systolic and Diastolic (mmHg) | Baseline, post-intervention, 18-24 months post intervention | 
| Fasting Blood Glucose | measured in mg/DL | Baseline, post-intervention, 18-24 months post intervention | 
| Waist and Hip Circumference | measured in inches | Baseline, post-intervention, 18-24 months post intervention | 
| Waist-to-Hip ratio | waist in inches/hips in inches | Baseline, post-intervention, 18-24 months post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disordered eating attitudes and behaviors | measured using the Eating Disorder Examination-Questionnaire (version 6), Range: 0-6, higher scores indicate worse outcome | baseline, post intervention, 18-24 months post intervention | 
| Intuitive eating behaviors | Ability to engage in 'adaptive' eating (e.g., recognize internal signs of hunger and satiety) measured the Intuitive Eating Scale. Range: 1-5, higher scores indicate a better outcome | baseline, post intervention, 18-24 months post intervention | 
| Maladaptive eating behaviors | Measured using the 'emotional eating' and 'uncontrolled eating' eating sub-scales of the Three-Factor Eating Questionnaire -Revised 18, Range: 0-100, higher scores indicate worse outcome | baseline, post intervention, 18-24 months post intervention | 
| Fruit and vegetable intake | Assessed with the questions: I eat 2 or more servings of fruit/vegetables on average each day. from the Red Lotus Health and Well-being Questionnaire, Range 0: (none of the time) to 5 (all of the time), higher scores indicate better outcome | baseline, post intervention, 18-24 months post intervention | 
| Physical activity | Assessed with the question: I participate in moderately vigorous physical activity for about 30 minutes on average most days of the week. from the Red Lotus Health and Well-being Questionnaire, Range 0: (none of the time) to 5 (all of the time), higher scores indicate better outcome | baseline, post intervention, 18-24 months post intervention | 
| Self-esteem | measured using the Rosenberg Self-esteem Scale, Range: 0-30, higher scores indicate a better outcome | baseline, post intervention, 18-24 months post intervention | 
| Overall health and well-being status/Quality of life | measured using the Red Lotus Health and Well-being Questionnaire, Range: 15-75, higher scores indicate a better outcome | baseline, post intervention, 18-24 months post intervention | 
| Psychological distress | measured using the Depression Anxiety Stress Scale-21, Range: 0-168, higher scores indicate a worse outcome | baseline, post intervention, 18-24 months post intervention | 
| Dietary habits | Assessment of foods most often consumed, measured using the Dietary Risk Assessment screener, Range 0-125, higher scores indicate higher worse outcome | baseline, post intervention, 18-24 months post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, wellness, cardiovascular disease prevention, health at every size, weight loss