A Method to Deliver Automated and Tailored Intervention Content: 24-month Clinical Trial

Miller, Hailey; Voils, Corrine I.; Cronin, Kate; Jeanes, Elizabeth; Hawley, Jeffrey; Porter, Laura S.; Adler, Rachel; Sharp, Whitney; Pabich, Samantha; Gavin, Kara L.; Lewis, Megan A.; Johnson, Heather M.; Yancy, William S.; Gray, Kristen E.; Shaw, Ryan

doi:10.2196/38262

Cited by 3 publications

(1 citation statement)

References 28 publications

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“…REDCap uses Twilio's collection of APIs to send Short Message Service (SMS) messages to study participants. 36 If smartwatch wear time is <8 h on a given day or if it has been >24 h since a data sync, REDCap will send a text message to the participant's or parent's cell phone or mobile device to remind the participant to wear the device and upload data or contact the study team with difficulties. If heart rate exceeds 80% CPET maximum, REDCap will message the participant to remind them to adhere to heart rate goals and stay beneath maximum threshold.…”

Section: Text Messagingmentioning

confidence: 99%

Creating a digital approach for promoting physical activity in pediatric pulmonary hypertension: A framework for future interventions

Avitabile,

Mota,

Yeaman

et al. 2024

Pulm. circ.

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Children with pulmonary hypertension (PH) often demonstrate limited exercise capacity. Data support exercise as an effective nonpharmacologic intervention among adults with PH. However, data on exercise training in children and adolescents are limited, and characteristics of the optimal exercise program in pediatric PH have not been identified. Exercise programs may have multiple targets, including muscle deficits which are associated with exercise limitations in both adult and pediatric PH. Wearable accelerometer sensors measure physical activity volume and intensity in the naturalistic setting and can facilitate near continuous data transfer and bidirectional communication between patients and the study team when paired with informatics tools during exercise interventions. To address the knowledge gaps in exercise training in pediatric PH, we designed a prospective, single arm, nonrandomized pilot study to determine feasibility and preliminary estimates of efficacy of a 16‐week home exercise intervention, targeting lower extremity muscle mass and enriched by wearable mobile health technology. The exercIse Training in pulmONary hypertEnsion (iTONE) trial includes (1) semistructured exercise prescriptions tailored to the participant's baseline level of activity and access to resources; (2) interval goal setting fostering self‐efficacy; (3) real time monitoring of activity via wearable devices; (4) a digital platform enabling communication and feedback between participant and study team; (5) multiple avenues to assess participant safety. This pilot intervention will provide information on the digital infrastructure needed to conduct home‐based exercise interventions in PH and will generate important preliminary data on the effect of exercise interventions in youth with chronic cardiorespiratory conditions to power larger studies in the future.

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Section: Text Messagingmentioning

confidence: 99%

Creating a digital approach for promoting physical activity in pediatric pulmonary hypertension: A framework for future interventions

Avitabile,

Mota,

Yeaman

et al. 2024

Pulm. circ.

View full text Add to dashboard Cite

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Outcomes from Partner2Lose: a randomized controlled trial to evaluate 24-month weight loss in a partner-assisted intervention

Voils,

Shaw,

Gavin

et al. 2024

BMC Public Health

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Background Partner support is associated with better weight loss outcomes in observational studies, but randomized trials show mixed results for including partners. Unclear is whether teaching communication skills to couples will improve weight loss in a person attempting weight loss (index participant). Purpose To compare the efficacy of a partner-assisted intervention versus participant-only weight management program on 24-month weight loss. Methods This community-based study took place in Madison, WI. Index participants were eligible if they met obesity guideline criteria to receive weight loss counseling, were aged 18–74 years, lived with a partner, and had no medical contraindications to weight loss; partners were aged 18–74 years and not underweight. Couples were randomized 1:1 to a partner-assisted or participant-only intervention. Index participants in both arms received an evidence-based weight management program. In the partner-assisted arm, partners attended half of the intervention sessions, and couples were trained in communication skills. The primary outcome was index participant weight at 24 months, assessed by masked personnel; secondary outcomes were 24-month self-reported caloric intake and average daily steps assessed by an activity tracker. General linear mixed models were used to compare group differences in these outcomes following intent-to-treat principles. Results Among couples assigned to partner-assisted (n = 115) or participant-only intervention (n = 116), most index participants identified as female (67%) and non-Hispanic White (87%). Average baseline age was 47.27 years (SD 11.51 years) and weight was 106.55 kg (SD 19.41 kg). The estimated mean 24-month weight loss was similar in the partner-assisted (2.66 kg) and participant-only arms (2.89 kg) (estimated mean difference, 0.23 kg [95% CI, -1.58, 2.04 kg], p=0.80). There were no differences in 24-month average daily caloric intake (estimated mean difference 50 cal [95% CI: -233, 132 cal], p=0.59) or steps (estimated mean difference 806 steps [95% CI: -1675, 64 steps], p=0.07). The percentage of participants reporting an adverse event with at least possible attribution to the intervention did not differ by arm (partner-assisted: 9%, participant-only, 3%, p = 0.11). Conclusions Partner-assisted and individual weight management interventions led to similar outcomes in index participants. Trial registration Clinicaltrials.gov NCT03801174, January 11, 2019.

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Primary outcomes from Partner2Lose: A randomized controlled trial to evaluate partner involvement on long-term weight loss

Voils,

Shaw,

Gavin

et al. 2024

Preprint

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Background: Partner support is associated with better weight loss outcomes in observational studies, but randomized trials show mixed results for including partners. Unclear is whether teaching communication skills to couples will improve weight loss in index participants. Purpose: To compare the efficacy of a partner-assisted intervention versus participant-only weight management program on long-term weight loss. Methods: This community-based study took place in Madison, WI. Index participants were eligible if they met obesity guideline criteria to receive weight loss counseling, were aged 74 years or younger, lived with a partner, and had no medical contraindications to weight loss; partners were aged 74 years or younger and not underweight. Couples were randomized 1:1 to a partner-assisted or participant-only intervention. Index participants in both arms received an evidence-based weight management program. In the partner-assisted arm, partners attended half of the intervention sessions, and couples were trained in communication skills. The primary outcome was index participant weight at 24 months, assessed by masked personnel; secondary outcomes were 24-month self-reported caloric intake and average daily steps assessed by an activity tracker. General linear mixed models were used to compare group differences in these outcomes following intent-to-treat principles. Results: Among couples assigned to partner-assisted (n=115) or participant-only intervention (n=116), most index participants identified as female (67%) and non-Hispanic White (87%). Average baseline age was 47.27 years (SD 11.51 years) and weight was 106.55 kg (SD 19.41 kg). The estimated mean 24-month weight loss was similar in the partner-assisted (2.66 kg) and participant-only arms (2.89 kg) (estimated mean difference, 0.23 kg [95% CI, -1.58, 2.04 kg]). There were no differences in 24-month average daily caloric intake (50 cal [95% CI: -233, 132 cal]) or steps (806 steps [95% CI: -1675, 64 steps]). The percentage of participants reporting an adverse event with at least possible attribution to the intervention did not differ by arm (partner-assisted: 9%, participant-only, 3%, p=0.11). Conclusions: Partner-assisted and individual weight management interventions led to similar outcomes in index participants. Trial registration: Clinicaltrials.gov NCT03801174

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A Method to Deliver Automated and Tailored Intervention Content: 24-month Clinical Trial

Cited by 3 publications

References 28 publications

Creating a digital approach for promoting physical activity in pediatric pulmonary hypertension: A framework for future interventions

Creating a digital approach for promoting physical activity in pediatric pulmonary hypertension: A framework for future interventions

Outcomes from Partner2Lose: a randomized controlled trial to evaluate 24-month weight loss in a partner-assisted intervention

Primary outcomes from Partner2Lose: A randomized controlled trial to evaluate partner involvement on long-term weight loss

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