1. Clinical Trial of a Mobile Health Intervention for Simultaneous versus Sequential Diet and Activity Change
Bonnie Spring, PhD.
Director, Center for Behavior and Health
Northwestern University FSM, Chicago, Illinois
AHA Sessions Late Breaking Clinical Trial, Orlando, FL, 11/15

2. The Make Better Choices (MBC) Randomized Clinical Trials
Diet and activity CVD risk behaviors are prevalent & co-occurring. Does intervening on multiple behaviors simultaneously produce positive synergies or negative overwhelm?
MBC1*
N = 204 adults have ALL of:
ALL of:
low fruit/vegetables (FV) = < 5 /day
high saturated fat (Sat) => 8% kcal
low moderate-vigorous physical activity (MVPA) =< 60 min/day
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
↑ Healthy Eat (FV+)
↑ Healthy Act (PA+)
↑ Healthy Eat (FV+)
↓Unhealthy Act (Sed-)
↓Unhealthy Eat (Fat-)
↑ Healthy Act (PA+)
↓ Unhealthy Eat (Fat-)
↓Unhealthy Act (Sed-)
*Spring, Schneider, ….Lloyd-Jones (2012), Arch Internal Med, 172(10),
9/17/2018

3. Make Better Choices 1 Results
↑FV↓Sed Improved All Behaviors Except MVPA
↑FV↓Sed Maximized Healthy Change
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?
9/17/2018

4. 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*)
Hypotheses: Simultaneous and Sequential > Control; Sequential > Simultaneous
*Pellegrini, Steglitz…Spring (2015) Contemporary Clinical Trials, 41, 85-92
9/17/2018

5. MBC2 Smartphone Apps
Sequential
Simultaneous
Control
9/17/2018

6. Participant Characteristics
9/17/2018

7. Mean (+SE) Composite Z Diet/Activity Improvement Over Time* * *
Both Sequential and Simultaneous Treatments Produced Large Magnitude, Sustained Healthy Change in Diet and Activity
Error bars represent 1 SE. Gray background = treatment initiation phase (weeks 0-12); white background = follow-up maintenance
9/17/2018

8. Effects of the 3 interventions on changes in each behavior (expressed in natural units)
* Trt vs. C
¥ Sim vs Seq * * * * *
6m M diff: min/day, 95% CI [0.7, 30.9]
9m M diff: -3.7%,
95% CI [-5.4, -2.1]
9m M diff: min/day, 95% CI
[-153.4, ]
9m M diff: 5.9 day
95% CI [4.5, 7.2]
9/17/2018

9. Adherence 15/84 = 18% 16/84 = 19% 7/44 = 16% n.s. 84% 82% 75% n.s 65%
Sequential
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%
3 Month arcsin % Days Self-Monitored
1.11 (77%)
1.03 (75%)
.79 (59%)
6 Month arcsin % Days Self-Monitored
.97 (68%)
.91 (65%)
.73 (52%)
9 Months arcsin % Days Self-Monitored
.83 (58%)
.73 (56%)
.66 (46%)
9/17/2018

10. 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.

11. Acknowledgements Coauthors Funders 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.
NHLBI R01 HL (Spring)
NCI K07 CA (Siddique)
NCATS UL1TR (Northwestern University)
Clinical Trial Registration: URL: Unique Identifier: NCT

12. Thank you!