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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Wellness-Centered (HUGS); Behavioral: Weight-Centered (LEARN)

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • West Reading, Pennsylvania, United States, 19611
      • The Reading Hospital and Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: behavior based weight loss program

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Internalized weight stigma (putative mediator and moderator)	Degree to which someone personally endorses and adopts negative attitudes about higher weight bodies for themselves. Measured using the Weight Bias Internalization Scale, Range: 1-7, higher scores indicate worse outcome	baseline, post intervention,18-24 months post intervention

Collaborators and Investigators

• Sponsor: The Reading Hospital and Medical Center
• Collaborators: The Edna G. Kynett Memorial Foundation
• Investigators: Principal Investigator: Janell L Mensinger, Ph.D., Villanova University

Publications and helpful links

General Publications

• Mensinger JL, Calogero RM, Stranges S, Tylka TL. A weight-neutral versus weight-loss approach for health promotion in women with high BMI: A randomized-controlled trial. Appetite. 2016 Oct 1;105:364-74. doi: 10.1016/j.appet.2016.06.006. Epub 2016 Jun 8.
• Mensinger JL, Calogero RM, Tylka TL. Internalized weight stigma moderates eating behavior outcomes in women with high BMI participating in a healthy living program. Appetite. 2016 Jul 1;102:32-43. doi: 10.1016/j.appet.2016.01.033. Epub 2016 Jan 29.
• Mensinger, J. L., & Meadows, A. (2017). Internalized weight stigma mediates and moderates physical activity outcomes during a healthy living program for women with high body mass index. Psychology of Sport and Exercise, 30, 64-72. doi:10.1016/j.psychsport.2017.01.010

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2008
• Primary Completion (Actual): February 25, 2011
• Study Completion (Actual): February 25, 2011

Study Registration Dates

• First Submitted: October 8, 2008
• First Submitted That Met QC Criteria: October 8, 2008
• First Posted (Estimate): October 9, 2008

Study Record Updates

• Last Update Posted (Actual): December 3, 2019
• Last Update Submitted That Met QC Criteria: November 27, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: obesity; weight loss; wellness; cardiovascular disease prevention; health at every size
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: TRHMC 02708