Clinical trial NCT00769717: Evaluation of a Health at Every Size vs a Behavioral Weight Loss Approach for Obese Women
Official title: Comparative Health Improvements and Rate of Relapse in Weight-Centered vs. Wellness-Centered Interventions for Obese Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity
wellness
cardiovascular disease prevention
health at every size
weight loss
Lead sponsor: The Reading Hospital and Medical Center
Sponsor class: OTHER
Collaborators: name: The Edna G. Kynett Memorial Foundation
First posted: 2008-10-09
Enrollment: 80
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 Parallel assignment
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Blood Lipids
timeFrame: Baseline, post-intervention, 18-24 months post intervention
measure: Blood Pressure
timeFrame: Baseline, post-intervention, 18-24 months post intervention
measure: Fasting Blood Glucose
timeFrame: Baseline, post-intervention, 18-24 months post intervention
measure: Waist and Hip Circumference
timeFrame: Baseline, post-intervention, 18-24 months post intervention
measure: Waist-to-Hip ratio
timeFrame: Baseline, post-intervention, 18-24 months post intervention
Secondary outcomes:
measure: Disordered eating attitudes and behaviors
timeFrame: baseline, post intervention, 18-24 months post intervention
measure: Intuitive eating behaviors
timeFrame: baseline, post intervention, 18-24 months post intervention
measure: Maladaptive eating behaviors
timeFrame: baseline, post intervention, 18-24 months post intervention
measure: Fruit and vegetable intake
timeFrame: baseline, post intervention, 18-24 months post intervention
measure: Physical activity
timeFrame: baseline, post intervention, 18-24 months post intervention
measure: Self-esteem
timeFrame: baseline, post intervention, 18-24 months post intervention
measure: Overall health and well-being status/Quality of life
timeFrame: baseline, post intervention, 18-24 months post intervention
measure: Psychological distress
timeFrame: baseline, post intervention, 18-24 months post intervention
measure: Dietary habits
timeFrame: baseline, post intervention, 18-24 months post intervention
Other outcomes:
measure: Internalized weight stigma (putative mediator and moderator)
timeFrame: baseline, post intervention,18-24 months post intervention
Locations:
city: West Reading
country: United States
facility: The Reading Hospital and Medical Center
state: Pennsylvania
Study officials:
affiliation: Villanova University
name: Janell L Mensinger, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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