Look AHEAD (Action for Health in Diabetes): design and methods for a clinical trial of weight loss for the prevention of cardiovascular disease in type 2 diabetes

Ryan, Donna H.; Espeland, Mark A.; Foster, Gary D.; Haffner, Steven M.; Hubbard, Van S.; Johnson, Karen C.; Kahn, Steven E.; Knowler, William C.; Yanovski, Susan Z.

doi:10.1016/s0197-2456(03)00064-3

Cited by 708 publications

(468 citation statements)

References 33 publications

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“…Similarly, although the lifestyle intervention provided in the DPP study was estimated (in year 2000 dollars) to cost $1,399 in year 1 ($162 per month) 13, the DPP has been translated into community‐based programmes (e.g. YMCA) that typically last 1 year and cost $400 to $600 per participant (or $33–$60 per month) 14. Clearly, the variability in these costs relates to the intensity of the programme (i.e.…”

Section: Introductionmentioning

confidence: 99%

Cost of intervention delivery in a lifestyle weight loss trial in type 2 diabetes: results from the Look AHEAD clinical trial

Rushing

Wing

Wadden

et al. 2017

Obesity Science & Practice

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SummaryObjectiveThe Action for Health in Diabetes (Look AHEAD) trial was a randomized controlled clinical trial to compare the effects of 10 years of intensive lifestyle intervention (ILI) with a control condition of diabetes support and education (DSE) on health outcomes in over 5,000 participants with type 2 diabetes. The ILI had significantly greater weight losses than DSE throughout the trial. The goal of this analysis is to describe the cost of delivering the intervention.MethodsThe ILI was designed to promote weight loss and increase physical activity. It involved a combination of group plus individual intervention sessions, with decreasing frequency of contact over the 10 years. The intervention incorporated a variety of strategies, including meal replacement products, to improve weight loss outcomes. The costs of intervention delivery were derived from staff surveys of effort and from records of intervention materials from the 16 US academic clinical trial sites. Costs were calculated from the payer perspective and presented in 2012 dollars.ResultsDuring the first year, when intervention delivery was most intensive, the annual cost of intervention delivery, averaged (standard deviation) across clinical sites, was $2,864.6 ($513.3) per ILI participant compared with $202.4 ($76.6) per DSE participant. As intervention intensity declined, costs decreased, such that from years 5 to 9 of the trial, the annual cost of intervention was $1,119.8 ($227.7) per ILI participant and $102.9 ($33.0) per DSE participant. Staffing accounted for the majority of costs throughout the trial, with meal replacements and materials to promote adherence accounting for smaller shares.ConclusionsThe sustained weight losses produced by the Look AHEAD intervention were supported by intervention costs that were within the range of other weight loss programmes. Future work will include an evaluation of the cost‐effectiveness of the ILI and will contain additional follow‐up data.

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Section: Introductionmentioning

confidence: 99%

Cost of intervention delivery in a lifestyle weight loss trial in type 2 diabetes: results from the Look AHEAD clinical trial

Rushing

Wing

Wadden

et al. 2017

Obesity Science & Practice

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show abstract

“…Look AHEAD is a multi-center randomized clinical trial that has enrolled 5,145 overweight or obese volunteers with type 2 diabetes [Look AHEAD, 2003]. It has been designed to assess the long-term effects on cardiovascular outcomes of an intensive lifestyle intervention program designed to achieve and maintain weight loss by decreased caloric intake and increased physical activity.…”

Section: Methodsmentioning

confidence: 99%

“…Data on factors were collected by standardized questionnaires, either self-or staffadministered, or by clinical measures obtained from trained and certified technicians, as discussed in greater detail elsewhere [Look AHEAD, 2003]. History of hyperlipidemia was defined as either a measured low density lipoprotein cholesterol (LDL-C) >130 mg/dl and/or use of a lipid lowering agent.…”

Section: Baseline Data Collection Variable Definitions and Data Anamentioning

confidence: 99%

Consent for genetics studies among clinical trial participants: findings from Action for Health in Diabetes (Look AHEAD)

Espeland

Dotson²,

Jaramillo³

et al. 2006

Clinical Trials

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“…The goal of recruitment was to achieve equal numbers of men and women and a minimum of 33% of participants from racial/ethnic minority groups and to have Յ30% of participants taking insulin. Exclusion criteria included inadequate control of diabetes (i.e., A1C Ͼ11%), factors affecting a participant's ability to adhere to interventions, and underlying diseases likely to limit life span and/or affect the safety of the interventions (15). All participants gave informed consent, consistent with the Helsinki Declaration and approved by the institutional review board of each center.…”

mentioning

confidence: 99%

Weight Loss Strategies Associated With BMI in Overweight Adults With Type 2 Diabetes at Entry Into the Look AHEAD (Action for Health in Diabetes) Trial

et al. 2008

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OBJECTIVE -Intentional weight loss is recommended for those with type 2 diabetes, but the strategies patients attempt and their effectiveness for weight management are unknown. In this investigation we describe intentional weight loss strategies used and those related to BMI in a diverse sample of overweight participants with type 2 diabetes at enrollment in the Look AHEAD (Action for Health in Diabetes) clinical trial. RESEARCH DESIGN AND METHODS-This was a cross-sectional study of baseline weight loss strategies, including self-weighing frequency, eating patterns, and weight control practices, reported in 3,063 women and 2,082 men aged 45-74 years with BMI Ն25 kg/m 2 .RESULTS -Less than half (41.4%) of participants self-weighed Ն1/week. Participants ate breakfast 6.0 Ϯ 1.8 days/week, ate 5.0 Ϯ 3.1 meals/snacks per day, and ate 1.9 Ϯ 2.7 fast food meals/week. The three most common weight control practices (increasing fruits and vegetables, cutting out sweets, and eating less high-carbohydrate foods) were reported by ϳ60% of participants for Ն20 weeks over the previous year. Adjusted models showed that self-weighing less than once per week (B ϭ 0.83), more fast food meals consumed per week (B ϭ 0.14), and fewer breakfast meals consumed per week (B ϭ Ϫ0.19) were associated (P Ͻ 0.05) with a higher BMI (R 2 ϭ 0.24).CONCLUSIONS -Regular self-weighing and breakfast consumption, along with infrequent consumption of fast food, were related to lower BMI in the Look AHEAD study population.

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Look AHEAD (Action for Health in Diabetes): design and methods for a clinical trial of weight loss for the prevention of cardiovascular disease in type 2 diabetes

Cited by 708 publications

References 33 publications

Cost of intervention delivery in a lifestyle weight loss trial in type 2 diabetes: results from the Look AHEAD clinical trial

Cost of intervention delivery in a lifestyle weight loss trial in type 2 diabetes: results from the Look AHEAD clinical trial

Consent for genetics studies among clinical trial participants: findings from Action for Health in Diabetes (Look AHEAD)

Weight Loss Strategies Associated With BMI in Overweight Adults With Type 2 Diabetes at Entry Into the Look AHEAD (Action for Health in Diabetes) Trial

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