Dataset Information

Rationale and description of a lifestyle intervention programme to achieve moderate weight loss in women with non-metastatic breast cancer: the lifestyle intervention part of the SUCCESS C Study.

ABSTRACT:

Objective

There is growing evidence from observational studies that lifestyle factors such as obesity, an unhealthy diet and lack of physical activity are associated with poor long-term outcome in women with breast cancer. The primary objective of the lifestyle modification part of the Simultaneous Study of Docetaxel Based Anthracycline Free Adjuvant Treatment Evaluation, as well as Life Style Intervention Strategies (SUCCESS C) Trial is to investigate the effect of an individualised lifestyle intervention programme aiming at moderate weight loss on disease-free survival in women with HER2/neu-negative breast cancer. Secondary objectives include the effect of the intervention on body weight, cardiovascular risk and quality of life.

Methods

The SUCCESS C Trial is an open-label, multicentre, randomised controlled phase III study using a 2×2 factorial design in women with newly diagnosed HER2/neu-negative intermediate-risk to high-risk breast cancer. The first randomisation served to compare disease-free survival in patients treated with two different chemotherapy regimens (3642 participants). The second randomisation served to compare disease-free survival in patients with a body mass index of 24-40?kg/m² (2292 participants) receiving either a telephone-based individualised lifestyle intervention programme for moderate weight loss or general recommendations for a healthy lifestyle for 2?years. Outcome analyses will be conducted after 5 years of follow-up.

Perspective

This study will provide information on the efficacy and safety of a comprehensive lifestyle intervention programme on disease-free survival in a large cohort of women with breast cancer. EU Clinical Trials Identifier: 2008-005453-38.

SUBMITTER: Hauner D

PROVIDER: S-EPMC7841841 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Rationale and description of a lifestyle intervention programme to achieve moderate weight loss in women with non-metastatic breast cancer: the lifestyle intervention part of the SUCCESS C Study.

Hauner Dagmar D Rack Brigitte B Friedl Thomas T Hepp Philip P Janni Wolfgang W Hauner Hans H

BMJ nutrition, prevention & health 20200921 2

<h4>Objective</h4>There is growing evidence from observational studies that lifestyle factors such as obesity, an unhealthy diet and lack of physical activity are associated with poor long-term outcome in women with breast cancer. The primary objective of the lifestyle modification part of the Simultaneous Study of Docetaxel Based Anthracycline Free Adjuvant Treatment Evaluation, as well as Life Style Intervention Strategies (SUCCESS C) Trial is to investigate the effect of an individualised lif ...[more]

PMID: 33521531

Similar Datasets

Project description:Background/objectives: Polycystic ovary syndrome (PCOS) is a common condition in reproductive-aged women. Weight management is a first-line treatment for PCOS according to international evidence-based guidelines. However, the factors associated with attrition or success in weight loss interventions are not known for women with PCOS. The objective of this study was to identify characteristics associated with attrition and weight loss success in women with PCOS and overweight or obesity undergoing weight loss interventions. Methods: Four randomised controlled clinical weight loss trials comprising energy restricted diets and/or exercise interventions of 2⁻8 months duration. The interventions were conducted over 2001⁻2007 in outpatient clinical research centres with n = 221 premenopausal women with PCOS and overweight/obesity recruited through community advertisement. The main outcome measures were attrition and ≥5% weight loss at 2 months and study completion. Results: Weight loss was 5.7 ± 2.9 kg at 2 months and 7.4 ± 5.3 kg after study completion (p < 0.001). Attrition was 47.1% and ≥5% weight loss occurred in 62.5% and 62.7% of women at 2 months and study completion respectively. Baseline depressive symptoms (OR 1.07 95% CI 0.88, 0.96, p = 0.032) and lower appointment attendance by 2 months (OR 0.92 95% CI 0.88, 0.96, p < 0.001) were independently associated with attrition. Lower appointment attendance over the whole study was independently associated with not achieving ≥5% weight loss at study completion (OR 0.95 95% CI 0.92, 0.99, p = 0.020). Conclusions: Despite high attrition, successful weight loss was achieved by 63% of women with PCOS in a clinical research setting. Higher baseline depressive symptoms were associated with greater attrition and higher appointment attendance was associated with lower attrition and greater weight loss success. These finding have implications for development of successful weight management programs in PCOS.

Project description:BACKGROUND:Evidence-informed practice is fundamental to the delivery of high quality health care. Delays and gaps in the translation of research into practice can impact negatively on patient care. Previous studies have reported that problems facing health care professionals such as information overload, underdeveloped critical appraisal skills, lack of time and other individual, organisational and system-level contextual factors are barriers to the uptake of evidence. Health services research in this area has been restricted largely to the evaluation of program outcomes. This paper aims to describe the implementation process of an educational initiative for health care professionals working in midwifery, neonatology or obstetrics aimed at disseminating evidence and enhancing evidence-informed clinical care. METHODS:We designed and implemented an educational initiative called Evidence Rounds for health care professionals working in the women and children's division of an urban hospital in Ireland. It consisted of three core components: (1) group educational sessions examining evidence on topics chosen by staff (2) a dedicated website and (3) facilitation, enablement and support from a knowledge translation professional. We evaluated user engagement in the educational program by monitoring attendance figures and website analytics. We followed up with staff at 3, 16 and 21-month intervals after the last educational session to find out whether evidence had been implemented. We use Lavis's organising framework for knowledge transfer and the Template for Intervention Description and Replication (TIDieR) checklist to describe the educational program and document the implementation process. RESULTS:Six educational sessions presented by 18 health care professionals took place over a nine month period with 148 attendances of which 85 were unique (individuals who attended at least one session). During the period spanning from one month before, during and one month after the running of the group sessions, 188 unique visitors, 331 visits and 862 page views were recorded on our website. CONCLUSIONS:Audit and feedback processes can provide quantitative data to track practice outcomes. Achieving sustainable educational programs can be challenging without dedicated resources such as staffing and funding.

Project description:BackgroundWeight loss improves cardiovascular risk factors and "quality of life". Most therapeutic approaches fail to induce a sustained weight loss and most individuals undergo weight regain. In this paper the comprehensive design of the "MAINTAIN" study, all assessments as well as the one year lifestyle intervention will be outlined in detail.Methods/designOne-center randomized controlled trial with seven assessment time points conducted 2009-2015. For the randomization eight groups were distinguished in a list to allocate intervention or control group: Females and males either pre-pubertal or pubertal and with a BMI-SDS under or over 2.5.SettingWeight loss at a residential weight reduction programme Berlin/Brandenburg and intervention at a paediatric outpatient clinic;Participants137 children and adolescents (10 to 17 years).InterventionPARTICIPANTS were randomized after an initial weight loss at a residential weight reduction programme and allocated to intervention (n=65) and control (n=72) conditions. The intervention group received an one-year group multi-professional lifestyle intervention with monthly meetings at the paediatric outpatient obesity clinic. The control group had a free living phase for one year and both groups 48 months follow up.Main outcome measuresPARTICIPANTS who are engaged in monthly intervention meetings will benefit in terms of a sustained weight maintenance. The primary aim is to describe the dynamic of hormonal and metabolic mechanisms counter-balancing sustained weight loss during puberty and adolescence. The secondary aim is to investigate the effect of an intensive family based lifestyle intervention during the weight maintenance period on the endogenous counter-regulation as well as on health related quality of life. The third aim is to establish predictors for successful weight maintenance and risk factors for weight regain in obese children and adolescents.DiscussionWeight maintenance after induced weight loss is one of the most important therapeutic challenges as long as most patients fail to maintain their weight loss. MAINTAIN is the first paediatric RCT addressing in parallel to a RCT in obese adults the course of weight regain after induced weight loss and is embedded in an experimental research consortium in order to also address several molecular mechanisms of weight regain.Trial registrationClinicalTrials NCT00850629, first registration 17 February 2009, verified January 2012, Paediatric part of the interventional study. Ethic proposal approved at 08.04.2009.

Project description:BackgroundExcess gestational weight gain (GWG) is common among women with overweight or obesity, increasing their risks for pregnancy complications, delivering a large infant, and postpartum weight retention. To date, only intensive interventions have had success and few interventions have been designed for implementation in healthcare settings.MethodsWe describe the development, rationale, and methods of GLOW (GestationaL Weight Gain and Optimal Wellness), a randomized controlled trial evaluating the efficacy of a lifestyle intervention to prevent excess GWG among racially/ethnically diverse women with overweight or obesity in an integrated healthcare delivery system. Participants in Kaiser Permanente Northern California will be randomized, within 2 weeks of completing a study baseline clinic visit at 10 weeks' gestation, to either usual medical care or a multi-component pregnancy lifestyle intervention adapted from the Diabetes Prevention Program (target N = 400). Informed by focus groups with patients and designed to be feasible in a clinical setting, the intervention will include 13 weekly individual sessions (11 delivered by telephone) focused on behavior change for weight management, healthy eating, physical activity, and stress management. Outcomes will be assessed in women and their infants from randomization to 12 months postpartum. The primary outcome is GWG. Secondary outcomes include changes in diet and physical activity during pregnancy and infant birthweight. Exploratory outcomes include cardiometabolic profile assessed via pregnancy blood samples and cord blood samples; and postpartum weight retention and infant anthropometrics up to 12 months of age. The trial includes systematic approaches to enhance intervention fidelity, intervention adherence, and participant retention in trial assessments.DiscussionGLOW is among few trials targeting excess GWG among diverse women with overweight or obesity in a healthcare setting, with long-term maternal and infant outcomes assessed up to 12 months after delivery. This evaluation of a multi-component intervention is designed to produce generalizable results to inform potential adoption of the intervention in clinical settings.Trial registrationClinicalTrials.gov ( NCT02130232 ): submitted April 30, 2014; posted May 5, 2014.

Dataset Information

Rationale and description of a lifestyle intervention programme to achieve moderate weight loss in women with non-metastatic breast cancer: the lifestyle intervention part of the SUCCESS C Study.

Objective

Methods

Perspective

Publications

Rationale and description of a lifestyle intervention programme to achieve moderate weight loss in women with non-metastatic breast cancer: the lifestyle intervention part of the SUCCESS C Study.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets