This is a multisite clinical trial of healthy lifestyle programs for middle-to-older-aged adults (50 -74 years) to improve their weight and, therefore, reduce risk for chronic disease. This study will investigate whether a proven, self-directed video-based lifestyle program can be significantly enhanced with the assistance of a coach via videoconference or phone to help people as they adopt healthy eating and exercise behaviors. Additionally, the study will examine what factors might explain why some people achieve better outcomes than others. Understanding this can help to tailor the program to an individual for personalized care in the future. Importantly, this study aims to demonstrate how readily a digital lifestyle program, with or without remote coaching, can be seamlessly delivered to patients at home via the patient portal of their electronic health record. This practical use of existing telehealth tools could be a feasible and effective means to offer behavioral treatments during routine medical care.
This multisite clinical trial uses a 2-stage sequential randomization design to test the adaptive and nonadaptive augmentation of a validated Group Lifestyle Balance (GLB) video program (base intervention) using problem solving treatment (PST), a proven behavior therapy. The GLB video program will be delivered via the patient portal of the electronic health record system. Trained coaches will deliver PST remotely via videoconference or phone. English-speaking adults (N=1029), 50-74 years of age with a body mass index ≥27 and ≥1 cardiometabolic conditions, will be randomized at baseline to base intervention or waitlist control. Participants initially randomized to the waitlist control will be re-randomized after a 12-week control period to receive the base (Group A) or the augmented intervention (Group B), without tailoring based on early weight loss. Among participants initially randomized to the base intervention, responders defined by ≥3% weight loss at 6 weeks will continue the base intervention (Group C); nonresponders who are participants with \<3% weight loss or missing weight data by 6 weeks will be re-randomized to continue the base intervention alone (Group D) or augmented with PST coaching via videoconference (Group E). We hypothesize: (1) the augmented intervention will be more effective than the base intervention both among early nonresponders to the base intervention (adaptive) and among participants in the waitlist control condition (nonadaptive) at 52 weeks; (2) the adaptive augmented intervention will be more efficacious than the base intervention and more efficacious than the waitlist control condition at 12 weeks. Aim 2 is to identify predictors of clinically significant (5%) weight loss for individual patients, using sociodemographic, clinical and behavioral engagement characteristics.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,029
12 Group Lifestyle Balance videos and digital motivational messages
12 Group Lifestyle Balance videos and digital motivational messages plus remote coaching for one-on-one and group-based problem-solving treatment via videoconference (preferred) or phone
Department of Medicine, Vitoux Program on Aging and Prevention
Chicago, Illinois, United States
Washington University School of Medicine in St Louis
St Louis, Missouri, United States
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, United States
Assess change in weight from baseline to 52 weeks
All participants will be provided a Fitbit Aria weight scale, a Fitbit Inspire 3 activity tracker, and a study tablet (Samsung Galaxy). At baseline (0) and 52 weeks, a study coordinator at each site who is blinded to randomization will proactively contact participants by phone, email, and/or text to remind them to weigh themselves at the same time on at least 3 days during the week. Participants will be instructed to weigh themselves on their study-provided Aria scale right after waking up and emptying their bladder (and bowel, if possible). They should wear only a t-shirt and undergarments, and bare feet. We will obtain participants' self-monitored weight data using a developed program for automated daily synchronization via the Fitbit open API.
Time frame: Baseline, 52 weeks
Assess change in weight from baseline to 12 weeks
All participants will be provided a Fitbit Aria weight scale, a Fitbit Inspire 3 activity tracker, and a study tablet (Samsung Galaxy). At baseline (0) and 12 weeks, a study coordinator at each site who is blinded to randomization will proactively contact participants by phone, email, and/or text to remind them to weigh themselves at the same time on at least 3 days during the week. Participants will be instructed to weigh themselves on their study-provided Aria scale right after waking up and emptying their bladder (and bowel, if possible). They should wear only a t-shirt and undergarments, and bare feet. We will obtain participants' self-monitored weight data using a developed program for automated daily synchronization via the Fitbit open API.
Time frame: Baseline, 12 weeks,
Assess trajectories of weight change from baseline to 6, 12, 24, and 52 weeks
All participants will be provided a Fitbit Aria weight scale, a Fitbit Inspire 3 activity tracker, and a study tablet (Samsung Galaxy). At baseline (0), 6, 12, 24, and 52 weeks, a study coordinator at each site who is blinded to randomization will proactively contact participants by phone, email, and/or text to remind them to weigh themselves at the same time on at least 3 days during the week. Participants will be instructed to weigh themselves on their study-provided Aria scale right after waking up and emptying their bladder (and bowel, if possible). They should wear only a t-shirt and undergarments, and bare feet. We will obtain participants' self-monitored weight data using a developed program for automated daily synchronization via the Fitbit open API.
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks
Assess changes in number of steps using Fitbit activity tracker at 6, 12, 24 and 52 weeks
All participants will receive a study-provided Fitbit Inspire 3 activity tracker with heart rate and sleep monitor, assistance with account and device setup. At 0, 6, 12, 24 and 52 weeks, a study coordinator at each site who is blinded to randomization will proactively contact participants by phone, email, and/or text to remind them to wear their activity tracker for at least 10 hours on 3 or more days during the week. We will obtain participants' self-monitored number of steps using a developed program for automated daily synchronization via the Fitbit open API.
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks, 52 weeks
Assess changes in physical activity using the International Physical Activity Questionnaire at 6, 12, 24 and 52 weeks
All participants will self-administer the International Physical Activity Questionnaire (IPAQ), a 7-item questionnaire that captures a participant's physical activity over the last 7 days.
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks, 52 weeks
Assess changes in fruit/veggie/fat/fiber intake at 6, 12, 24 and 52 weeks
Dietary intake will be measured using 17-item fruit, vegetable, fat, and fiber screener by self-report. Correlations between screener estimates and estimated true intake were 0.5-0.8.
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks, 52 weeks
Assess changes in efficacy in weight control at 6, 12, 24 and 52 weeks
Participants will complete validated self-administered scale of self-efficacy for weight control using the Weight Efficacy Lifestyle Questionnaire. Sum of scores of 8 items, with a range between 0 and 80. Higher scores indicate higher self-efficacy to control eating behaviors.
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks, 52 weeks
Assess changes in efficacy in diet change at 6, 12, 24 and 52 weeks
Participants will complete validated self-administered scale of self-efficacy for dietary change using the Eating Habits Confidence Survey. The total score is mean item scores, with a range between 1 and 5. Higher scores indicate higher diet self-efficacy (i.e., higher ability to avoid eating certain unhealthy foods).
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks, 52 weeks
Assess changes in efficacy in physical activity at 6, 12, 24 and 52 weeks
Participants will complete validated self-administered scale of self-efficacy for physical activity using the Exercise Confidence Survey. The total score is mean item scores, with a range between 1 and 5. Higher scores indicate higher exercise self-efficacy (i.e., greater confidence in performing certain behaviors consistently for at least 6 months).
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks, 52 weeks
Assess changes in social support/autonomous support per Health Care Climate Questionnaire at 6, 12, 24 and 52 weeks
Participants will complete the Health Care Climate Questionnaire (HCCQ), which assessed their perceptions of the autonomy supportiveness of their care team. HCCQ contains 15 items, rated on a 5-point scale ranging from "not true at all" to "very true." After reversing the score of a negative item, an average score is calculated with higher score indicating a higher level of perceived autonomy support.
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks, 52 weeks
Assess changes in problem solving ability at 6, 12, 24 and 52 weeks
Participants' problem solving abilities will be assessed using the reliable and valid SPSI-R:S that contains 25 items in the following 5 subscales: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving (RPS), impulsive/careless style (ICS), and avoidance style (AS). Each item is rated on a 5-point scale ranging from "not at all true of me" (0) to "extremely true of me" (4). SPSI-R:S is a short version of the long SPSI-R:L form which has Cronbach's alpha coefficient of 0.95 for the total score and of 0.67-0.92 for subscales.
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks, 52 weeks
Assess changes in patient activation at 6, 12, 24 and 52 weeks
The 13-item PAM measures patient's self-reported knowledge, skill, and confidence for self-managing his or her health condition. It demonstrated acceptable internal consistency (Conbrach's alpha = 0.81). The 13-item PAM score accounts for 92% of the variation in the activity measured by the original 22-item PAM. The score is also significantly correlated with general preventive behaviors and disease-specific self-management behaviors.
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks, 52 weeks
Assess changes in perceived stress at 6, 12, 24 and 52 weeks
Perceived Stress Scale (PSS) measures the perception of stress (i.e., the degree to which situations in one's life are appraised as stressful). PSS contains 14 items, rated on a 5-point scale ranging from "never" to "very often." After reversing the scores on 7 positive items, a sum of score is calculated with higher score indicating higher perceived stress. Cronbach's alpha ranged from 0.84 to 0.86.
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks, 52 weeks
Assess changes in sleep disturbance score at 6, 12, 24 and 52 weeks
Sleep disturbance is assessed on the 8-item PROMIS sleep disturbance scale short form which measures symptoms of insomnia. Each item is scaled from 1 (not at all) to 5 (very much). Sleep disturbance score=(Raw sum ×number of items on the short form) / number of items answered. The higher the score the greater sleep disturbance.
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks, 52 weeks
Assess changes in sleep impairment score at 6, 12, 24 and 52 weeks
Sleep impairment is assessed on the 8-item PROMIS sleep-related impairment scale short form which measures symptoms of daytime sleepiness. Each item is scaled from 1 (not at all) to 5 (very much). Sleep impairment score=(Raw sum ×number of items on the short form) / number of items answered. The higher the score the greater sleep impairment.
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks, 52 weeks
Assess changes in cognitive functioning at 6, 12, 24 and 52 weeks
Cognitive functioning will be assessed on the PROMIS version 1.0 short-form subscales of Cognitive Abilities and Cognitive Concerns. Each subscale contains 8 items. The Cognitive Abilities items target positive self-assessments of cognitive functioning such as "My memory has been as good as usual" and "I have been able to concentrate." The Cognitive Concerns items are worded negatively and express concerns in the same areas, for examples, "My thinking has been slow" and "I have had trouble shifting back and forth between different activities that require thinking." Items on both subscales use a 5-point rating from "not at all" to "very much." Items are summed to create a total score for each subscale.
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks, 52 weeks
Assess changes in cardiovascular risk at 52 weeks
The non-laboratory Framingham risk prediction model estimates individuals' 10-year risk of developing any major atherosclerotic cardiovascular disease (CVD) event. The component risk factors are age, BMI, systolic blood pressure, smoking status, presence of diabetes, and medication for high blood pressure. Participants will be asked to confirm their age and report their smoking history at baseline and current smoking status at baseline and 52 weeks. The BMI will be calculated based on participants' self-measured weight data as described above and height measurements abstracted from their EHR. Blood pressure, diagnosis of diabetes, and prescriptions for high blood pressures will also be abstracted from the EHR.
Time frame: Baseline, 52 weeks
Assess changes in number/severity of comorbidity at 52 weeks
The Cumulative Illness Rating Scale (CIRS) is a composite index of the number and severity of medical problems by organ system. It has been validated in diverse populations and settings, including primary care patients, with published guidelines and electronic tools for application and scoring using electronic health record (EHR) data.
Time frame: Baseline, 52 weeks
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