Dose and timing of text messages for increasing physical activity among pregnant women: a randomized controlled trial

BACKGROUND High gestational weight gain is a major public health concern as it independently predicts adverse maternal and infant outcomes. Past interventions have had only limited success in effectively managing pregnancy weight gain, especially among women with overweight and obesity. Well-designed interventions are needed that take an individualized approach and target unique barriers to promote healthy weight gain. OBJECTIVE The primary aim of the study is to describe the study protocol for Healthy Mom Zone, an individually tailored, adaptive intervention for managing weight in pregnant women with overweight and obesity. METHODS The Healthy Mom Zone Intervention, based on theories of planned behavior and self-regulation and a model of energy balance, includes components (eg, education, self-monitoring, physical activity/healthy eating behaviors) that are adapted over the intervention (ie, increase in intensity) to better regulate weight gain. Decision rules inform when to adapt the intervention. In this randomized controlled trial, women are randomized to the intervention or standard care control group. The intervention is delivered from approximately 8-36 weeks gestation and includes step-ups in dosages (ie, Step-up 1 = education + physical activity + healthy eating active learning [cooking/recipes]; Step-up 2 = Step-up 1 + portion size, physical activity; Step-up 3 = Step-up 1 + 2 + grocery store feedback, physical activity); 5 maximum adaptations. Study measures are obtained at pre- and postintervention as well as daily (eg, weight), weekly (eg, energy intake/expenditure), and monthly (eg, psychological) over the study period. Analyses will include linear mixed-effects models, generalized estimating equations, and dynamical modeling to understand between-group and within-individual effects of the intervention on weight gain. RESULTS Recruitment of 31 pregnant women with overweight and obesity has occurred from January 2016 through July 2017. Baseline data have been collected for all participants. To date, 24 participants have completed the intervention and postintervention follow-up assessments, 3 are currently in progress, 1 dropped out, and 3 women had early miscarriages and are no longer active in the study. Of the 24 participants, 13 women have completed the intervention to date, of which 1 (8%, 1/13) received only the baseline intervention, 3 (23%, 3/13) received baseline + step-up 1, 6 (46%, 6/13) received baseline + step-up 1 + step-up 2, and 3 (23%, 3/13) received baseline + step-up 1 + step-up 2 +step-up 3. Data analysis is still ongoing through spring 2018. CONCLUSIONS This is one of the first intervention studies to use an individually tailored, adaptive design to manage weight gain in pregnancy. Results from this study will be useful in designing a larger randomized trial to examine efficacy of this intervention and developing strategies for clinical application. REGISTERED REPORT IDENTIFIER RR1-10.2196/9220

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Effect of physical activity trackers and daily text messages on quality-of-life in colorectal cancer survivors (Smart Pace): a pilot randomized controlled trial (Preprint)

10.2196/preprints.17442 ◽

2019 ◽

Author(s):

Hilary Chan ◽

Katherine Van Loon ◽

Stacey A Kenfield ◽

June Maylin Chan ◽

Emily Mitchell ◽

...

Keyword(s):

Quality Of Life ◽

Physical Activity ◽

Colorectal Cancer ◽

Randomized Controlled Trial ◽

Physical Activity Intervention ◽

Controlled Trial ◽

Well Being ◽

Text Messages ◽

Randomized Controlled

BACKGROUND There are over 1.3 million colorectal cancer (CRC) survivors in the United States, many of whom report lower health-related quality-of-life (HRQoL) for years after diagnosis and treatment. Physical activity may improve survival outcomes and HRQoL for CRC survivors. Feasible interventions to support physical activity after CRC diagnosis are needed. OBJECTIVE This pilot study aimed to explore the impact of digital health intervention on physical activity and HRQoL. METHODS We conducted a two-arm, randomized controlled trial of 41 men and women who had completed treatment for CRC. Participants in the intervention arm were given a Fitbit Flex™ and received daily text messages for 12 weeks. HRQoL was assessed in both arms at enrollment and 12 weeks using the Medical Outcomes Study Short Form Survey (SF-36) and the Functional Assessment of Cancer Treatment – Colorectal (FACT-C). Survey score changes from enrollment to 12 weeks were compared between the two arms using independent t-tests and scores at enrollment and 12 weeks were compared using paired t-tests. RESULTS We observed an increase in the FACT-C functional well-being sub-scale in individuals in the intervention arm pre- to post- intervention (median difference: 2; interquartile range (IQR): 1,4; P = .02). In contrast, no change in functional well-being sub-scale was found in the control arm (median difference: 0; IQR: -1,1; P = .71). No other measures of HRQoL appeared to differ within arm, across time points, or between arms. CONCLUSIONS A 12-week physical activity intervention using a Fitbit Flex™ and daily text messages may improve functional well-being among CRC survivors. Larger randomized studies are needed to definitively determine if a digital physical activity intervention improves functional well-being among CRC survivors and if this improvement can be sustained over time. CLINICALTRIAL ClinicalTrials.gov NCT02966054

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Effect of physical activity trackers and daily text messages on quality-of-life in colorectal survivors (Smart Pace): A pilot randomized controlled trial.

Journal of Clinical Oncology ◽

10.1200/jco.2018.36.4_suppl.559 ◽

2018 ◽

Vol 36 (4_suppl) ◽

pp. 559-559

Author(s):

Hilary Chan ◽

Katherine Van Loon ◽

Stacey A. Kenfield ◽

June M. Chan ◽

Emily Mitchell ◽

...

Keyword(s):

Quality Of Life ◽

Physical Activity ◽

Randomized Controlled Trial ◽

Physical Activity Intervention ◽

Controlled Trial ◽

Well Being ◽

Text Messages ◽

Randomized Controlled ◽

Sf 36

559 Background: There are over 1.3 million colorectal cancer (CRC) survivors in the United States, and many of whom suffer from lower health-related quality-of-life (HRQoL) years after diagnosis and treatment. Physical activity may improve survival outcomes and HRQoL for CRC survivors. Feasible interventions to support physical activity after CRC diagnosis are needed. Methods: We conducted a two-arm randomized controlled trial of 41 men and women who had completed treatment for CRC. Participants in the intervention arm were given a Fitbit Flex™ and received daily text messages for 12 weeks. HRQoL was assessed in both arms at baseline and 12 weeks using the RAND Short Form Survey (SF-36) and the Functional Assessment of Cancer Therapy – Colorectal (FACT-C). Survey score changes from baseline to 12 weeks were compared between the two arms using independent t-tests, and scores at baseline and 12 weeks were compared using paired t-tests. SAS was used for analysis, and statistical significance was declared at p < 0.05. Results: We observed a statistically significant increase in the FACT-C functional well-being sub-scale in individuals in the intervention arm pre- and post- intervention (mean ∆ 1.81 ± 2.76; p: 0.02). There was no change in functional well-being in the control arm (mean ∆ -0.35 ± 4.12; p: 0.71). The between-arm comparison of change from baseline to 12 weeks was not statistically significantly ( p: 0.08). There was a statistically significant increase in the FACT-C emotional well-being sub-scale in the control arm (mean ∆ 1.20 ± 2.48; p: 0.04) and in the SF-36 role physical sub-scale in the control arm (mean ∆ 22.5 ± 38.8; p: 0.02). No other measures of HRQoL were statistically significantly different within groups, across time points, or between groups. Conclusions: A 12-week physical activity intervention using a Fitbit Flex™ and daily text messages may improve functional well-being among CRC survivors. Larger randomized studies are needed to definitively determine if a digital physical activity intervention improves functional well-being among CRC survivors, and if the improvement can be sustained over time. Clinical trial information: NCT02966054.

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