Prepare, a randomized trial to promote and evaluate weight loss among overweight and obese women planning pregnancy: Study design and rationale.

Background: Women who are overweight or have obesity at pregnancy onset, and those who gain excessive weight during pregnancy, are at increased risk of pregnancy-related complications and large for gestational age infants.

Objective: This report describes methodology for the Prepare study, a randomized, controlled clinical trial testing a preconception and pregnancy weight management program for women who are overweight or have obesity (BMI≥27kg/m(2)).

Outcomes: This trial examines multiple pregnancy and neonatal outcomes, with the primary outcome being gestational weight gain (GWG).

The impact of continued intervention on weight: Five-year results from the weight loss maintenance trial.

Objective: In the Weight Loss Maintenance (WLM) Trial, a personal contact (PC) intervention sustained greater weight loss relative to a self-directed (SD) group over 30 months. This study investigated the effects of continued intervention over an additional 30 months and overall weight change across the entire WLM Trial.

Methods: WLM had 3 phases.

Maternal body mass index before pregnancy is associated with increased bronchodilator dispensing in early childhood: A cross-sectional study.

Rationale: Maternal prepregnancy obesity has been associated with early wheeze and childhood asthma in their offspring. Some of these studies have been in minority, urban, and disadvantaged populations using parental recall and questionnaires. The association of maternal prepregnancy obesity with bronchodilator dispensing to their offspring, in a primarily insured, non-urban, White population in the United States is unknown.

Do patient or provider characteristics impact management of diabetes?

Objectives: Patients with diabetes often exceed desired glycated hemoglobin (A1C) levels for months prior to medication adjustments. To determine if provider and patient characteristics predict glycemic control and treatment intensification.

Study Design: Observational retrospective cohort study using electronic medical record data.

Evaluation of care management intensity and bariatric surgical weight loss.

Objectives: To examine the effect of pre- and postoperative care management on weight loss following bariatric surgery.

Study Design: We conducted a retrospective cohort study supplemented by cross-sectional surveys across 9 bariatric surgery centers.

Methods: Based on the intensity of patient contact, care management intensity (CMI) was defined as high, moderate, or low for preoperative programs, and high or low for postoperative programs.

Provider beliefs about diabetes treatment have little impact on glycemic control of their patients with diabetes.

Objective: To improve the health of people with diabetes, it is essential to identify why patients experience extended periods of poor glycemic control before therapeutic intensification.

Research Design And Methods: We surveyed 252 primary care providers at Kaiser Permanente Northwest to determine their beliefs about the glycemic goals of their patients, treatment intensification behavior, and barriers to achieving optimal glycemic control. We linked the responses of 149 providers to the health records of their 18 346 patients with diabetes.

Predictors of dietary change among those who successfully lost weight in phase I of the Weight Loss Maintenance Trial.

Aim: Dietary changes occurring during weight loss interventions can vary. The present study tested if pretreatment psychosocial, dietary and demographic factors were associated with changes in fat intake and fruit and vegetable intake during a weight loss intervention.

Methods: This analysis includes participants who lost at least four kilograms during the initial six month weight loss phase (phase I) of the Weight Loss Maintenance Trial, a group format behavioural intervention emphasising a low-fat diet and increased physical activity.

Examining behavioral processes through which lifestyle interventions promote weight loss: results from PREMIER.

Objective: To examine the behavioral processes through which lifestyle interventions impacted weight loss.

Methods: The analyses were limited to overweight and obese Black and White adults randomized to a PREMIER lifestyle intervention (N = 501). Structural equation modeling was conducted to test the direct and indirect relationships of session attendance, days of self-monitoring diet and exercise, change in diet composition and exercise, and 6-month weight change.

Impact of participant and interventionist race concordance on weight loss outcomes.

Objective: We have previously shown that racial composition of behavioral intervention groups does not affect achieved weight loss. However, it is unclear if the race of the interventionist affects intervention outcomes. The objective of this analysis is to estimate the impact of race concordance between participant and interventionist on weight change in the initial weight loss phase (phase I) of the Weight Loss Maintenance trial (WLM).

Adherence to, and Satisfaction with, the Self-Acupressure Intervention in the LIFE Weight-Loss Maintenance Study.

Background: The LIFE study was a randomized controlled trial assessing the impact of a self-acupressure intervention, Tapas Acupressure Technique® (TAT®), on weight-loss maintenance. The primary analysis showed no significant difference between TAT and social support (SS) for weight-loss maintenance, while exploratory tests suggested that, among participants with highest initial weight-loss, those in the TAT condition regained less weight than those in the SS condition.

Objective: The aim of the current study was to assess adherence to, and satisfaction with, the experimental self-acupressure intervention in the LIFE weight loss maintenance trial.

Weight loss history as a predictor of weight loss: results from Phase I of the weight loss maintenance trial.

Past studies have suggested that weight loss history is associated with subsequent weight loss. However, questions remain whether method and amount of weight lost in previous attempts impacts current weight loss efforts. This study utilized data from the Weight Loss Maintenance Trial to examine the association between weight loss history and weight loss outcomes in a diverse sample of high-risk individuals.

Use of alternative medicine for weight loss among Mexican-American women.

The objective of this study is to examine the use of complementary and alternative medicine (CAM) for weight loss among Mexican-American women. Cross-sectional survey of different CAM modalities, including traditional Mexican medicine therapies. The sample was drawn from women participating in a weight-loss program in Portland, Oregon.

Randomized trial of Tapas Acupressure Technique for weight loss maintenance.

Background: Obesity is an urgent public health problem, yet only a few clinical trials have systematically tested the efficacy of long-term weight-loss maintenance interventions. This randomized clinical trial tested the efficacy of a novel mind and body technique for weight-loss maintenance.

Methods: Participants were obese adults who had completed a six-month behavioral weight-loss program prior to randomization.

Comparison of characteristics and outcomes by initial study contact (website versus staff) for participants enrolled in a weight management study.

Background: Traditional recruitment methods for clinical trials, such as telephone, mail, and print media, are often inefficient, costly, and use large amounts of staff time and resources.

Purpose: This analysis was conducted to determine whether retention, demographics, and outcomes differed between enrolled participants who responded to recruitment outreach using an Internet-based information and registration system and enrollees whose first contact was with study staff via telephone.

Methods: We identified potentially eligible participants from Kaiser Permanente Northwest (KPNW) databases and mailed brochures inviting them to participate in the Life weight loss maintenance study.

Dietary intakes associated with successful weight loss and maintenance during the Weight Loss Maintenance trial.

Background: Dietary components effective in weight maintenance efforts have not been adequately identified.

Objective: To determine the effects of changes in dietary consumption on weight loss and maintenance during the Weight Loss Maintenance clinical trial.

Design: Weight Loss Maintenance was a randomized controlled trial.

Development and Implementation of a Tailored Self-assessment Tool in an Internet-based Weight Loss Maintenance Program.

Background: Using the Internet to replicate client/counselor interactions provides a tremendous opportunity to disseminate interventions at relatively low cost per participant. However, there are substantial challenges with this approach. The Weight Loss Maintenance Trial (WLM) compared two long-term weight-maintenance interventions: (1) a personal contact arm and (2) an Internet arm, to a third self-directed control arm.

Associations of internet website use with weight change in a long-term weight loss maintenance program.

Background: The Weight Loss Maintenance Trial (WLM) compared two long-term weight-maintenance interventions, a personal contact arm and an Internet arm, with a no-treatment control after an initial six-month Phase I weight loss program. The Internet arm focused on use of an interactive website for support of long-term weight maintenance. There is limited information about patterns of website use and specific components of an interactive website that might help promote maintenance of weight loss.

Randomized trial of Tapas Acupressure Technique for weight loss maintenance: rationale and study design.

Objectives: The aim of this article is to present the rationale, study design, and methods of an ongoing randomized controlled trial assessing the efficacy of an energy psychology intervention, Tapas Acupressure Technique (TAT), to prevent weight regain following successful weight loss.

Design: This is a randomized controlled trial.

Settings/location: The study is being conducted at a large group-model health maintenance organization (HMO).

Development and implementation cost analysis of telephone- and Internet-based interventions for the maintenance of weight loss.

Objectives: The Weight Loss Maintenance Trial (WLM) was a multicenter, randomized trial comparing two weight loss maintenance interventions, a personal contact (PC) program with primarily telephone-based monthly contacts, and an Internet-based program (interactive technology, IT), to a self-directed control group, among overweight or obese individuals at high cardiovascular risk. This study describes implementation costs of both interventions as well as IT development costs.

Methods: Resources were micro-costed in 2006 dollars from the primary perspective of a sponsoring healthcare system considering adopting an extant intervention, rather than developing its own.

Weight loss during the intensive intervention phase of the weight-loss maintenance trial.

Background: To improve methods for long-term weight management, the Weight Loss Maintenance (WLM) trial, a four-center randomized trial, was conducted to compare alternative strategies for maintaining weight loss over a 30-month period. This paper describes methods and results for the initial 6-month weight-loss program (Phase I).

Methods: Eligible adults were aged > or =25, overweight or obese (BMI=25-45 kg/m2), and on medications for hypertension and/or dyslipidemia.

Comparison of strategies for sustaining weight loss: the weight loss maintenance randomized controlled trial.

Context: Behavioral weight loss interventions achieve short-term success, but re-gain is common.

Objective: To compare 2 weight loss maintenance interventions with a self-directed control group.

Design, Setting, And Participants: Two-phase trial in which 1032 overweight or obese adults (38% African American, 63% women) with hypertension, dyslipidemia, or both who had lost at least 4 kg during a 6-month weight loss program (phase 1) were randomized to a weight-loss maintenance intervention (phase 2).

Design and implementation of an interactive website to support long-term maintenance of weight loss.

Background: For most individuals, long-term maintenance of weight loss requires long-term, supportive intervention. Internet-based weight loss maintenance programs offer considerable potential for meeting this need. Careful design processes are required to maximize adherence and minimize attrition.

The PREMIER intervention helps participants follow the Dietary Approaches to Stop Hypertension dietary pattern and the current Dietary Reference Intakes recommendations.

Objective: To examine the influence of the PREMIER study lifestyle interventions on dietary intakes and adherence to the Dietary Approaches to Stop Hypertension (DASH) dietary pattern and the Dietary Reference Intakes (DRI).

Design: An 18-month multicenter, randomized controlled trial comparing two multicomponent lifestyle intervention programs to an advice only control group.

Subjects/setting: A total of 810 participants were recruited from local communities and randomized into the study.

PREMIER--a trial of lifestyle interventions for blood pressure control: intervention design and rationale.

Interventions encouraging adoption of healthy diets and increased physical activity are needed to achieve national goals for preventing and treating hypertension, cardiovascular disease, diabetes, and other chronic diseases. PREMIER was a multicenter clinical trial testing the effects of two lifestyle interventions on blood pressure control, compared with advice only. Both interventions implemented established national guidelines for blood pressure control (weight loss, reduced sodium and alcohol intake, and increased physical activity), and one intervention also included the Dietary Approaches to Stop Hypertension (DASH) diet.