Optimizing a Just-in-Time Adaptive Intervention to Improve Dietary Adherence in Behavioral Obesity Treatment: Protocol for a Microrandomized Trial

Background Behavioral obesity treatment (BOT) is a gold standard approach to weight loss and reduces the risk of cardiovascular disease. However, frequent lapses from the recommended diet stymie weight loss and prevent individuals from actualizing the health benefits of BOT. There is a need for innovative treatment solutions to improve adherence to the prescribed diet in BOT. Objective The aim of this study is to optimize a smartphone-based just-in-time adaptive intervention (JITAI) that uses daily surveys to assess triggers for dietary lapses and deliver interventions when the risk of lapse is high. A microrandomized trial design will evaluate the efficacy of any interventions (ie, theory-driven or a generic alert to risk) on the proximal outcome of lapses during BOT, compare the effects of theory-driven interventions with generic risk alerts on the proximal outcome of lapse, and examine contextual moderators of interventions. Methods Adults with overweight or obesity and cardiovascular disease risk (n=159) will participate in a 6-month web-based BOT while using the JITAI to prevent dietary lapses. Each time the JITAI detects elevated lapse risk, the participant will be randomized to no intervention, a generic risk alert, or 1 of 4 theory-driven interventions (ie, enhanced education, building self-efficacy, fostering motivation, and improving self-regulation). The primary outcome will be the occurrence of lapse in the 2.5 hours following randomization. Contextual moderators of intervention efficacy will also be explored (eg, location and time of day). The data will inform an optimized JITAI that selects the theory-driven approach most likely to prevent lapses in a given moment. Results The recruitment for the microrandomized trial began on April 19, 2021, and is ongoing. Conclusions This study will optimize a JITAI for dietary lapses so that it empirically tailors the provision of evidence-based intervention to the individual and context. The finalized JITAI will be evaluated for efficacy in a future randomized controlled trial of distal health outcomes (eg, weight loss). Trial Registration ClinicalTrials.gov NCT04784585; http://clinicaltrials.gov/ct2/show/NCT04784585 International Registered Report Identifier (IRRID) DERR1-10.2196/33568

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Optimizing a Just-in-Time Adaptive Intervention to Improve Dietary Adherence in Behavioral Obesity Treatment: Protocol for a Microrandomized Trial (Preprint)

10.2196/preprints.33568 ◽

2021 ◽

Author(s):

Stephanie P Goldstein ◽

Fengqing Zhang ◽

Predrag Klasnja ◽

Adam Hoover ◽

Rena R Wing ◽

...

Keyword(s):

Cardiovascular Disease ◽

Weight Loss ◽

Disease Risk ◽

Cardiovascular Disease Risk ◽

Treatment Protocol ◽

Time Of Day ◽

Obesity Treatment ◽

Just In Time ◽

Adaptive Intervention ◽

Contextual Moderators

BACKGROUND Behavioral obesity treatment (BOT) is a gold standard approach to weight loss and reduces the risk of cardiovascular disease. However, frequent lapses from the recommended diet stymie weight loss and prevent individuals from actualizing the health benefits of BOT. There is a need for innovative treatment solutions to improve adherence to the prescribed diet in BOT. OBJECTIVE The aim of this study is to optimize a smartphone-based just-in-time adaptive intervention (JITAI) that uses daily surveys to assess triggers for dietary lapses and deliver interventions when the risk of lapse is high. A microrandomized trial design will evaluate the efficacy of any interventions (ie, theory-driven or a generic alert to risk) on the proximal outcome of lapses during BOT, compare the effects of theory-driven interventions with generic risk alerts on the proximal outcome of lapse, and examine contextual moderators of interventions. METHODS Adults with overweight or obesity and cardiovascular disease risk (n=159) will participate in a 6-month web-based BOT while using the JITAI to prevent dietary lapses. Each time the JITAI detects elevated lapse risk, the participant will be randomized to no intervention, a generic risk alert, or 1 of 4 theory-driven interventions (ie, enhanced education, building self-efficacy, fostering motivation, and improving self-regulation). The primary outcome will be the occurrence of lapse in the 2.5 hours following randomization. Contextual moderators of intervention efficacy will also be explored (eg, location and time of day). The data will inform an optimized JITAI that selects the theory-driven approach most likely to prevent lapses in a given moment. RESULTS The recruitment for the microrandomized trial began on April 19, 2021, and is ongoing. CONCLUSIONS This study will optimize a JITAI for dietary lapses so that it empirically tailors the provision of evidence-based intervention to the individual and context. The finalized JITAI will be evaluated for efficacy in a future randomized controlled trial of distal health outcomes (eg, weight loss). CLINICALTRIAL ClinicalTrials.gov NCT04784585; http://clinicaltrials.gov/ct2/show/NCT04784585 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/33568

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Abstract P249: A Behavioral Weight Loss Intervention is Effective for Change in CVD Risk Factors in Young Adults: The IDEA Study

Circulation ◽

10.1161/circ.131.suppl_1.p249 ◽

2015 ◽

Vol 131 (suppl_1) ◽

Author(s):

John M Jakicic ◽

Kelliann K Davis ◽

Bethany Barone Gibbs ◽

Diane Helsel ◽

Wendy C King ◽

...

Keyword(s):

Risk Factors ◽

Cardiovascular Disease ◽

Weight Loss ◽

Young Adults ◽

Disease Risk ◽

Cardiovascular Disease Risk ◽

Cardiovascular Disease Risk Factors ◽

Weight Loss Intervention ◽

Behavioral Weight Loss ◽

Behavioral Weight Loss Intervention

Introduction: Few studies have examined behavioral weight loss interventions with respect to change in cardiovascular disease risk factors in young adults (aged 18 to 35 years). Hypothesis: We tested the hypothesis that a 6 month behavioral weight loss intervention resulted in significant improvements in selective cardiovascular disease risk factors in young adults. Methods: Data are presented as median [25 th , 75 th percentiles]. 470 participants (age: 30.9 [27.8, 33.7] years); BMI: 31.2 [28.4, 34.3] kg/m 2 ) were enrolled in a 6 month behavioral weight loss intervention that included weekly group sessions and prescribed an energy restricted diet and moderate-to-vigorous physical activity. Assessments included weight using a standardized protocol, resting blood pressure, and fasting lipids, glucose, and insulin. Statistical significance of change was according to tests of symmetry or the Wilcoxon matched pairs signed ranks test. Results: The primary outcome (weight) was available for 424 of the 470 participants (90.2%). Weight significantly decreased (-7.8 kg [-12.2, -3.7]) (p<0.0001). Systolic (-4.0 mmHg [-8.5, 0.5] and diastolic blood pressure (-3.0 mmHg [-6.5, 1.0]) decreased (p<0.0001). Total cholesterol (-13 mg/dl [-28.0, 2.0]), LDL cholesterol (-9.5 mg/dl [-21.7, 2.0]), triglycerides (-8.5 mg/dl [-44.0, 9.0]), glucose (-4.0 mg/dl [-8.0, 1.0]), and insulin (-2.6 mIU/L [-5.9, 0.7]) decreased (p<0.0001, n=416). There was not a significant change in HDL cholesterol (p=0.72). Conclusions: In conclusion, after 6 months, weight loss was observed in young adults assigned to this behavioral intervention that focused on physical activity and diet modification. They tended to also have improved cardiovascular disease risk factors. This may demonstrate an approach to reducing cardiovascular disease risk in young adults. Supported by NIH (U01HL096770) and AHA (12BGIA9410032)

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Time-of-day and Meal Size Effects on Clinical Lipid Markers

The Journal of Clinical Endocrinology & Metabolism ◽

10.1210/clinem/dgaa739 ◽

2020 ◽

Author(s):

Leilah K Grant ◽

Charles A Czeisler ◽

Steven W Lockley ◽

Shadab A Rahman

Keyword(s):

Cardiovascular Disease ◽

Total Cholesterol ◽

Disease Risk ◽

Cardiovascular Disease Risk ◽

Density Lipoprotein ◽

Time Of Day ◽

Lipoprotein Cholesterol ◽

Shift Workers ◽

Postprandial Lipid Metabolism ◽

Lipid Panel

Abstract Context Dyslipidemia and cardiovascular disease are common in shift workers and eating at night may contribute to this pathophysiology. Objective To examine the effects of eating at different times of day on lipid profiles. Design Two 24-hour baseline days with 8 hours of sleep, 3 meals (breakfast, lunch, dinner) and a snack, followed by a 40-hour constant routine (CR) with hourly isocaloric meals. Setting Intensive Physiological Monitoring Unit, Brigham and Women’s Hospital. Participants Twenty-one healthy adults [23.4 ± 2.7 years, 5F] Intervention Forty-hour CR. Main Outcome Measures A standard clinical lipid panel, consisting of total cholesterol, triglyceride (TG), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C), was assayed in blood samples collected 4-hourly across ~4 days. Results When participants ate at night, levels of TG were similar to eating during the day, however, these levels at night were reached with consuming approximately half the calories. Additionally, 24-hour levels of TG were 10% higher when meals were consumed hourly across 24 hours compared to consuming a typical 3-meal schedule while awake during the day and sleeping at night. The endogenous circadian rhythms of TG, which peaked at night, were shifted earlier by ~10 hours under baseline conditions, whereas the rhythms in total cholesterol, HDL-C, and LDL-C remained unchanged and peaked in the afternoon. Conclusions The time-of-day dependency on postprandial lipid metabolism, which leads to hypersensitivity in TG responses when eating at night, may underlie the dyslipidemia and elevated cardiovascular disease risk observed in shift workers.

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