Clinical Trial of a Mobile Health Intervention for Simultaneous versus Sequential Diet and Activity Change

Bonnie Spring, PhD.Director, Center for Behavior and HealthNorthwestern University FSM, Chicago, Illinoisbspring@northwestern.edu

AHA Sessions Late Breaking Clinical Trial, Orlando, FL, 11/15

The Make Better Choices (MBC) Randomized Clinical Trials

• MBC1*• N = 204 adults have ALL of:

• ALL of:1. low fruit/vegetables (FV) = < 5 /day2. high saturated fat (Sat) => 8% kcal3. low moderate-vigorous physical activity

(MVPA) =< 60 min/day4. high sedentary leisure screen time (Sed) =

>120 min/day.

• Outcome: composite z healthy diet + activity improvement weighting all behaviors equally

• Compared ↑healthy/↓unhealthy X eating/activity

• Mobile self-monitoring tool (PDA) with feedback• Data transmitted to telephone coach

• Paid $175 to reach 50% goal by 1 week; maintain 100% goal for 2 weeks

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Diet and activity CVD risk behaviors are prevalent & co-occurring. Does intervening on multiple behaviors simultaneously produce positive synergies or negative overwhelm?

*Spring, Schneider, ….Lloyd-Jones (2012), Arch Internal Med, 172(10), 789-796

↑ Healthy Eat (FV+)↑ Healthy Act (PA+)

↑ Healthy Eat (FV+)↓Unhealthy Act (Sed-)

↓Unhealthy Eat (Fat-)↑ Healthy Act (PA+)

↓ Unhealthy Eat (Fat-)↓Unhealthy Act (Sed-)

Make Better Choices 1 Results

↑FV↓Sed Maximized Healthy Change ↑FV↓Sed Improved All Behaviors Except MVPA

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• Can we preserve healthy change when removing large payment contingent on behavior change?

• Can we also improve MVPA without undermining improvement in FV, Sed, Fat?

Make Better Choices 2 (MBC2)* N: 212 adults with all 4 risk behaviors: low FV, high Sat, low MVPA, high Sed

Randomized to 3 Treatments• Sequential (target FV, Sed first, then

MVPA) • Simultaneous (MVPA, FV, Sed)• Control (Stress & Sleep).

Outcome: composite z diet and activity improvement at 6 & 9 months

Treatment Phases• Initiation: 12 weekly coaching calls: reach 1/3 goal every

2 wks• Maintenance: biweekly check-in 3- 6 mo f/up; monthly 6-9 mo. f/up

• Android app (+ loaned phone prn)

• Wireless accelerometer.

• $5 incentive each week during 12 weeks when all goals met (*rarely attained*)

•

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Hypotheses: Simultaneous and Sequential > Control; Sequential > Simultaneous

*Pellegrini, Steglitz…Spring (2015) Contemporary Clinical Trials, 41, 85-92

MBC2 Smartphone Apps

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Sequential Simultaneous Control

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Participant Characteristics

Mean (+SE) Composite Z Diet/Activity Improvement Over Time

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Error bars represent 1 SE. Gray background = treatment initiation phase (weeks 0-12); white background = follow-up maintenance

Both Sequential and Simultaneous Treatments Produced Large Magnitude, Sustained Healthy Change in Diet and Activity

¥

* * *

Effects of the 3 interventions on changes in each behavior (expressed in natural units)

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9m M diff: 5.9 day 95% CI [4.5, 7.2]

9m M diff: 126.9 min/day, 95% CI [-153.4, -100.3]

9m M diff: -3.7%, 95% CI [-5.4, -2.1]

6m M diff: 15.8 min/day MVPA, 95% CI [0.7, 30.9]

* Trt vs. C¥ Sim vs Seq

* ** * *

¥

AdherenceSequential Simultaneous Control Significance

9 mo. Lost to Follow-Up

15/84 = 18% 16/84 = 19% 7/44 = 16% n.s.

Attends 3-Month Assessment

84% 82% 75% n.s

Attends 9-Month Assessment

65% 63% 59% n.s.

3 Month arcsin % Days Self-Monitored

1.11 (77%) 1.03 (75%) .79 (59%) n.s.

6 Month arcsin % Days Self-Monitored

.97 (68%) .91 (65%) .73 (52%) n.s.

9 Months arcsin % Days Self-Monitored

.83 (58%) .73 (56%) .66 (46%) n.s.

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Conclusions

• ITT analyses using linear mixed effects models showed that, even without large financial incentives for behavior change, Sequential and Simultaneous interventions produced sustained diet and activity improvement compared to Control (p<.001), and their effects were comparable.

• Attrition and adherence were similar across treatments and control.

• Both simultaneous and sequential intervention produced large magnitude composite diet and improvement, compared to control, that was sustained at 6 and 9 months.

• Both treatments increased fruit/vegetable intake, decreased sedentary leisure screen time and decreased saturated fat intake at 6 and 9 months. Both treatments increased MVPA at 6 months; the difference from control no longer reached significance at 9 months.

• Simultaneous or sequential treatment of multiple diet and activity risk behaviors using mobile technologies and remote coaching may produce large, sustained diet and activity improvements. Maintenance of MVPA improvement warrants additional research.

Acknowledgements

Coauthors

Northwestern University Christine A Pellegrini, Ph.D. H. G. McFadden, B.S. Angela F Pfammatter, Ph.D. Juned Siddique, Dr.P.H.

Stanford University Abby C. King, Ph.D.

University of Chicago Donald Hedeker, Ph.D.

Funders

• NHLBI R01 HL075451 (Spring)

• NCI K07 CA154862 (Siddique)

• NCATS UL1TR000150 (Northwestern University)

• Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique Identifier: NCT01249989

bspring@northwestern.edubspring@northwestern.edu