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

NCT00769717 | Completed

• 1 other identifier: TRHMC 02708
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Keywords

obesity; wellness; cardiovascular disease prevention; health at every size; weight loss

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (9)

• Disordered eating attitudes and behaviors

  baseline, post intervention, 18-24 months post intervention

• Intuitive eating behaviors

  baseline, post intervention, 18-24 months post intervention

• Maladaptive eating behaviors

  baseline, post intervention, 18-24 months post intervention

• Fruit and vegetable intake

  baseline, post intervention, 18-24 months post intervention

• Physical activity

  baseline, post intervention, 18-24 months post intervention

Other Outcomes (1)

• Internalized weight stigma (putative mediator and moderator)

  baseline, post intervention,18-24 months post intervention

Study Arms (2)

Wellness-Centered

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.

Behavioral: Wellness-Centered (HUGS)

Weight-Centered

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.

Behavioral: Weight-Centered (LEARN)

Interventions

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.

Also known as: Health At Every Size, Intuitive Eating

Wellness-Centered

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.

Also known as: behavior based weight loss program

Weight-Centered

Eligibility Criteria

• Age: 30 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Reading Hospital and Medical Center: lead
• The Edna G. Kynett Memorial Foundation: collaborator

Study Sites (1)

The Reading Hospital and Medical Center

West Reading, Pennsylvania, 19611, United States

Location

Related Publications (3)

• 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.

  PMID: 27289009 RESULT

• 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.

  PMID: 26829370 RESULT

• 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

  RESULT

Related Links

• Link to request first publication (main outcomes) from ResearchGate
• Link to request second publication (disordered eating mediation and moderation) from ResearchGate
• Link to request third publication (physical activity mediation and moderation) from ResearchGate

MeSH Terms

Conditions

Obesity; Weight Loss

Interventions

Educational Status

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Janell L Mensinger, Ph.D.

  Villanova University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: There was full allocation concealment through the 3-month recruitment phase of the trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Research Professor

Model Details: 1:1 Parallel assignment

Study Record Dates

• First Submitted: October 8, 2008
• First Posted: October 9, 2008
• Study Start: September 25, 2008
• Primary Completion: February 25, 2011
• Study Completion: February 25, 2011
• Last Updated: December 3, 2019

Record last verified: 2019-11

Locations

US (1)