Design of the Advancing Care for Type 1 Diabetes and Obesity Network energy metabolism and sequential multiple assignment randomized trial nutrition pilot studies: An integrated approach to develop weight management solutions for individuals with type 1 diabetes

Corbin, Karen D.; Igudesman, Daria; Addala, Ananta; Casu, Anna; Crandell, Jamie; Kosorok, Michael R.; Maahs, David M.; Pokaprakarn, Teeranan; Pratley, Richard E.; Souris, Katherine J.; Thomas, Joan; Zaharieva, Dessi P.; Mayer‐Davis, Elizabeth J.

doi:10.1016/j.cct.2022.106765

Cited by 9 publications

(10 citation statements)

References 65 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Several projects targeted substance use (k = 6) [18,[25][26][27][28][29][30][31]. weight management (k = 5) [20,24,[32][33][34][35], and smoking cessation (k = 4) [23,[36][37][38]; fewer targeted medication adherence (k = 3) [21,22,39,40], physical activity (k = 3) [41][42][43], and glycemic management (k = 1) [44]. The projects targeting medication adherence were focused on antiretroviral therapy (ART) for human immunodeficiency virus (HIV) [21,22,39] and preexposure prophylaxis (PrEP) for HIV prevention [40].…”

Section: Resultsmentioning

confidence: 99%

“…Additionally, most studies are using subsequent randomization for treatment nonresponders. In an effort to enhance effects for treatment non-responders, protocols are testing strategies to include adding incentives [21], adding human-delivered elements such as calls or counseling [34,36,37,42], adding prescription medication [31,36,38], adding texts [34,37,38], adding medication counseling or feedback [23,40], combining treatments [39], adding peer elements [43], and adding custom diets [34,44]. For example, Bucholz and colleagues [42] are enrolling 312 inactive women in a SMART aimed to increase physical activity.…”

Section: Resultsmentioning

confidence: 99%

“…Fernandez and colleagues are cluster randomizing wherein the first-stage clinics are randomized to opt-in or opt-out implementation strategies and patients are randomized at the second stage based on treatment response [37]. Corbin and colleagues randomize participants to one of three diets and rerandomize treatment nonresponders to unassigned diets resulting in participants being exposed to between one and three diets depending on treatment response [44]. Finally, Germeroth and colleagues are using a design where everyone is rerandomized, regardless of response status, such that some individuals remain with their original treatment assignment and others swap [20].…”

Section: Protocolsmentioning

confidence: 99%

See 2 more Smart Citations

Optimizing adaptive stepped-care interventions to change adults’ health behaviors: A systematic review

Roddy,

Pfammatter,

Mayberry

2023

J. Clin. Trans. Sci.

View full text Add to dashboard Cite

Chronic diseases are ubiquitous and costly in American populations. Interventions targeting health behavior change to manage chronic diseases are needed, but previous efforts have fallen short of producing meaningful change on average. Adaptive stepped-care interventions, that tailor treatment based on the needs of the individual over time, are a promising new area in health behavior change. We therefore conducted a systematic review of tests of adaptive stepped-care interventions targeting health behavior changes for adults with chronic diseases. We identified 9 completed studies and 13 research protocols testing adaptive stepped-care interventions for health behavior change. The most common health behaviors targeted were substance use, weight management, and smoking cessation. All identified studies test intermediary tailoring for treatment non-responders via sequential multiple assignment randomized trials (SMARTs) or singly randomized trials (SRTs); none test baseline tailoring. From completed studies, there were few differences between embedded adaptive interventions and minimal differences between those classified as treatment responders and non-responders. In conclusion, updates to this work will be needed as protocols identified here publish results. Future research could explore baseline tailoring variables, apply methods to additional health behaviors and target populations, test tapering interventions for treatment responders, and consider adults’ context when adapting interventions.

show abstract

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Protocolsmentioning

confidence: 99%

See 1 more Smart Citation

Optimizing adaptive stepped-care interventions to change adults’ health behaviors: A systematic review

Roddy,

Pfammatter,

Mayberry

2023

J. Clin. Trans. Sci.

View full text Add to dashboard Cite

show abstract

“…The design of the Advancing Care for Type 1 Diabetes and Obesity Network (ACTION) study has been described elsewhere. 15 Briefly, ACTION was a 9-month pilot feasibility and acceptability study conducted at the University of North Carolina at Chapel Hill (UNC) and Stanford University to identify acceptable and effective dietary strategies (hypocaloric low carbohydrate, hypocaloric Look AHEAD, or Mediterranean diet without calorie restriction) to co-optimize weight and glycaemia among adults with T1D aged 19-30 years (1DP3DK113358, NCT03651622). Primary outcomes were change in weight (kg), haemoglobin A1c (HbA1c) level, and percentage of time below range (%TBR; <70 mg/dl) 16 as assessed by continuous glucose monitoring (CGM) at baseline and following each of three, 3-month, dietary periods.…”

Section: Methodsmentioning

confidence: 99%

Weight management in young adults with type 1 diabetes: The advancing care for type 1 diabetes and obesity network sequential multiple assignment randomized trial pilot results

Igudesman

Crandell

Corbin

et al. 2022

Diabetes Obesity Metabolism

Self Cite

View full text Add to dashboard Cite

Aims: Co-management of weight and glycaemia is critical yet challenging in type 1 diabetes (T1D). We evaluated the effect of a hypocaloric low carbohydrate, hypocaloric moderate low fat, and Mediterranean diet without calorie restriction on weight and glycaemia in young adults with T1D and overweight or obesity. Materials and Methods:We implemented a 9-month Sequential, Multiple Assignment, Randomized Trial pilot among adults aged 19-30 years with T1D for ≥1 year and body mass index 27-39.9 kg/m 2 . Re-randomization occurred at 3 and 6 months if the assigned diet was not acceptable or not effective. We report results from the initial 3-month diet period and re-randomization statistics before shutdowns due to COVID-19 for primary [weight, haemoglobin A1c (HbA1c), percentage of time below range <70 mg/dl] and secondary outcomes [body fat percentage, percentage of time in range (70-180 mg/dl), and percentage of time below range <54 mg/dl]. Models adjusted for design, demographic and clinical covariates tested changes in outcomes and diet differences. Results: Adjusted weight and HbA1c (n = 38) changed by À2.7 kg (95% CI À3.8, À1.5, P < .0001) and À0.91 percentage points (95% CI À1.5, À0.30, P = .005), respectively, while adjusted body fat percentage remained stable, on average (P = .21). Hypoglycaemia indices remained unchanged following adjustment (n = 28, P > .05). Variability in all outcomes, including weight change, was considerable (57.9% were re-randomized primarily due to loss of <2% body weight). No outcomes varied by diet.

show abstract

“…Examples of precision health interventions are more limited than those of individualized interventions, which in part reflects the relatively recent advancements in complex trial designs and statistical methodology to make empirically based optimal treatment recommendations. Examples of SMART designs that have yielded or are intended to yield insights into treatment approaches for heterogeneous population have been applied in behavioral health, 36 plastic surgery, 37 and weight management, 38,39 among others. A review of clinicaltrials.gov shows a series of other SMARTs underway, including those focused on psychiatric diseases (NCT01588457), back pain (NCT05396014), and cancer pain (NCT02791646).…”

Section: Precision Health Interventions: Addressing Interindividual N...mentioning

confidence: 99%

Individualized interventions and precision health: Lessons learned from a systematic review and implications for analytics‐driven geriatric research

Kahkoska

Freeman

Jones

et al. 2022

J American Geriatrics Society

Self Cite

View full text Add to dashboard Cite

Older adults are characterized by profound clinical heterogeneity. When designing and delivering interventions, there exist multiple approaches to account for heterogeneity. We present the results of a systematic review of data‐driven, personalized interventions in older adults, which serves as a use case to distinguish the conceptual and methodologic differences between individualized intervention delivery and precision health‐derived interventions. We define individualized interventions as those where all participants received the same parent intervention, modified on a case‐by‐case basis and using an evidence‐based protocol, supplemented by clinical judgment as appropriate, while precision health‐derived interventions are those that tailor care to individuals whereby the strategy for how to tailor care was determined through data‐driven, precision health analytics. We discuss how their integration may offer new opportunities for analytics‐based geriatric medicine that accommodates individual heterogeneity but allows for more flexible and resource‐efficient population‐level scaling.

show abstract

Design of the Advancing Care for Type 1 Diabetes and Obesity Network energy metabolism and sequential multiple assignment randomized trial nutrition pilot studies: An integrated approach to develop weight management solutions for individuals with type 1 diabetes

Cited by 9 publications

References 65 publications

Optimizing adaptive stepped-care interventions to change adults’ health behaviors: A systematic review

Optimizing adaptive stepped-care interventions to change adults’ health behaviors: A systematic review

Weight management in young adults with type 1 diabetes: The advancing care for type 1 diabetes and obesity network sequential multiple assignment randomized trial pilot results

Individualized interventions and precision health: Lessons learned from a systematic review and implications for analytics‐driven geriatric research

Contact Info

Product

Resources

About