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Randomized Controlled Trial
. 2017 Aug 15;14(1):107.
doi: 10.1186/s12966-017-0564-1.

Comparison of an alternative schedule of extended care contacts to a self-directed control: a randomized trial of weight loss maintenance

Gareth R Dutton  1 , Marissa A Gowey  2 , Fei Tan  3 , Dali Zhou  3 , Jamy Ard  4 , Michael G Perri  5 , Cora E Lewis  2
Affiliations
Randomized Controlled Trial

Comparison of an alternative schedule of extended care contacts to a self-directed control: a randomized trial of weight loss maintenance

Gareth R Dutton et al. Int J Behav Nutr Phys Act. .

Abstract

Background: Behavioral interventions for obesity produce clinically meaningful weight loss, but weight regain following treatment is common. Extended care programs attenuate weight regain and improve weight loss maintenance. However, less is known about the most effective ways to deliver extended care, including contact schedules.

Methods: We compared the 12-month weight regain of an extended care program utilizing a non-conventional, clustered campaign treatment schedule and a self-directed program among individuals who previously achieved ≥5% weight reductions. Participants (N = 108; mean age = 51.6 years; mean weight = 92.6 kg; 52% African American; 95% female) who achieved ≥5% weight loss during an initial 16-week behavioral obesity treatment were randomized into a 2-arm, 12-month extended care trial. A clustered campaign condition included 12 group-based visits delivered in three, 4-week clusters. A self-directed condition included provision of the same printed intervention materials but no additional treatment visits. The study was conducted in a U.S. academic medical center from 2011 to 2015.

Results: Prior to randomization, participants lost an average of -7.55 ± 3.04 kg. Participants randomized to the 12-month clustered campaign program regained significantly less weight (0.35 ± 4.62 kg) than self-directed participants (2.40 ± 3.99 kg), which represented a significant between-group difference of 2.28 kg (p = 0.0154) after covariate adjustments. This corresponded to maintaining 87% and 64% of lost weight in the clustered campaign and self-directed conditions, respectively, which was a significant between-group difference of 29% maintenance of lost weight after covariate adjustments, p = 0.0396.

Conclusions: In this initial test of a clustered campaign treatment schedule, this novel approach effectively promoted 12-month maintenance of lost weight. Future trials should directly compare the clustered campaigns with conventional (e.g., monthly) extended care schedules.

Trial registration: Clinicaltrials.gov NCT02487121 . Registered 06/26/2015 (retrospectively registered).

Keywords: Adults; Behavioral treatment; Extended care; Obesity; Weight loss maintenance; Weight regain.

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Conflict of interest statement

Ethics approval and consent to participate

Approval for this study was obtained from the Institutional Review Board of the participating academic health center (protocol X111215003). Informed consent was obtained from all individual participants included in the study. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. This trial is registered with clinicaltrials.gov (NCT02487121).

Consent for publication

Informed consent was obtained from all participants for publication of data included in this manuscript. Individual participant data, images, or video are not included in this manuscript.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
CONSORT flow diagram
Fig. 2
Fig. 2
Mean weight change by extended care condition. Randomization occurred at month 4. Reported mean weight change includes unadjusted, observed means for 96 randomized participants who completed the follow-up assessment at month 16. Multiple linear regression indicated significantly less weight regain in the clustered campaign group vs. the self-directed group between months 4 and 16 (p = 0.0154)
See this image and copyright information in PMC

References

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