Skip to main content
OpenTrials
Completed

NCT Number: NCT00769717

Evaluation of a Health at Every Size vs a Behavioral Weight Loss Approach 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

30 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Reading Hospital and Medical Center

West Reading, Pennsylvania, 19611, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wellness-Centered (HUGS)

Behavioral

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

Weight-Centered (LEARN)

Behavioral

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

Primary outcomes

  1. Blood Lipids

    Time frame: Baseline, post-intervention, 18-24 months post intervention

    LDL, HDL, Total Cholesterol, Triglycerides (mg/dL)

  2. Blood Pressure

    Time frame: Baseline, post-intervention, 18-24 months post intervention

    Systolic and Diastolic (mmHg)

  3. Fasting Blood Glucose

    Time frame: Baseline, post-intervention, 18-24 months post intervention

    measured in mg/DL

  4. Waist and Hip Circumference

    Time frame: Baseline, post-intervention, 18-24 months post intervention

    measured in inches

  5. Waist-to-Hip ratio

    Time frame: Baseline, post-intervention, 18-24 months post intervention

    waist in inches/hips in inches

Secondary outcomes

  1. Disordered eating attitudes and behaviors

    Time frame: baseline, post intervention, 18-24 months post intervention

    measured using the Eating Disorder Examination-Questionnaire (version 6), Range: 0-6, higher scores indicate worse outcome

  2. Intuitive eating behaviors

    Time frame: baseline, post intervention, 18-24 months post intervention

    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

  3. Maladaptive eating behaviors

    Time frame: baseline, post intervention, 18-24 months post intervention

    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

  4. Fruit and vegetable intake

    Time frame: baseline, post intervention, 18-24 months post intervention

    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

  5. Physical activity

    Time frame: baseline, post intervention, 18-24 months post intervention

    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

  6. Self-esteem

    Time frame: baseline, post intervention, 18-24 months post intervention

    measured using the Rosenberg Self-esteem Scale, Range: 0-30, higher scores indicate a better outcome

  7. Overall health and well-being status/Quality of life

    Time frame: baseline, post intervention, 18-24 months post intervention

    measured using the Red Lotus Health and Well-being Questionnaire, Range: 15-75, higher scores indicate a better outcome

  8. Psychological distress

    Time frame: baseline, post intervention, 18-24 months post intervention

    measured using the Depression Anxiety Stress Scale-21, Range: 0-168, higher scores indicate a worse outcome

  9. Dietary habits

    Time frame: baseline, post intervention, 18-24 months post intervention

    Assessment of foods most often consumed, measured using the Dietary Risk Assessment screener, Range 0-125, higher scores indicate higher worse outcome

Other outcomes

  1. Internalized weight stigma (putative mediator and moderator)

    Time frame: baseline, post intervention,18-24 months post intervention

    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

Sponsors and collaborators

Lead sponsor

The Reading Hospital and Medical Center

Other

Collaborators

  • The Edna G. Kynett Memorial Foundation

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Oct 9, 2008
Registry last updated
Dec 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.