NCT00769717

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

Completed NA Last updated 3 December 2019

What this trial tests

NA trial testing Wellness-Centered (HUGS) in Obesity in 80 participants. Completed in 25 February 2011.

Timeline

25 September 2008

Primary endpoint
25 February 2011

25 February 2011

Quick facts

Lead sponsor	The Reading Hospital and Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	80
Start date	25 September 2008
Primary completion	25 February 2011
Estimated completion	25 February 2011
Sites	1 location across United States

Drugs / interventions tested

• Wellness-Centered (HUGS)
• Weight-Centered (LEARN)

Conditions studied

• Obesity — all drugs for Obesity →

Sponsor

The Reading Hospital and Medical Center

Who can join

Adults 30 to 45, female only, with Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.