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Research ArticleOriginal ResearchA

A Randomized Clinical Trial of a Tailored Lifestyle Intervention for Obese, Sedentary, Primary Care Patients

Charles B. Eaton, Sheri J. Hartman, Elizabeth Perzanowski, Guohui Pan, Mary B. Roberts, Patricia M. Risica, Kim M. Gans, John M. Jakicic and Bess H. Marcus
The Annals of Family Medicine July 2016, 14 (4) 311-319; DOI: https://doi.org/10.1370/afm.1952
Charles B. Eaton
1Alpert Medical School of Brown University, Providence, Rhode Island
2Department of Epidemiology, School of Public Health of Brown University, Providence, Rhode Island
3Center for Primary Care and Prevention, Memorial Hospital of Rhode Island, Pawtucket, Rhode Island
MD, MS, FAHA
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  • For correspondence: CEaton@CareNE.org
Sheri J. Hartman
4Department of Family Medicine and Public Health, University of California San Diego, La Jolla, California
5Cancer Prevention and Control, UC San Diego Moores Cancer Center, La Jolla, California
PhD
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Elizabeth Perzanowski
3Center for Primary Care and Prevention, Memorial Hospital of Rhode Island, Pawtucket, Rhode Island
BS
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Guohui Pan
3Center for Primary Care and Prevention, Memorial Hospital of Rhode Island, Pawtucket, Rhode Island
PhD
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Mary B. Roberts
3Center for Primary Care and Prevention, Memorial Hospital of Rhode Island, Pawtucket, Rhode Island
MS
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Patricia M. Risica
2Department of Epidemiology, School of Public Health of Brown University, Providence, Rhode Island
6Institute for Community Health Promotion, School of Public Health, Brown University, Providence, Rhode Island
DrPH
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Kim M. Gans
6Institute for Community Health Promotion, School of Public Health, Brown University, Providence, Rhode Island
7Department of Behavioral and Social Sciences, School of Public Health, Brown University, Providence, Rhode Island
8Department of Human Development and Family Studies, University of Connecticut, Storrs, Connecticut
9Center for Health Interventions and Prevention, University of Connecticut, Storrs, Connecticut
PhD
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John M. Jakicic
10Department of Health and Physical Activity, University of Pittsburgh, Pittsburgh, Pennsylvania
PhD
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Bess H. Marcus
4Department of Family Medicine and Public Health, University of California San Diego, La Jolla, California
PhD
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  • Article
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Article Figures & Data

Figures

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  • Figure 1
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    Figure 1

    CONSORT diagram of participant flow.

  • Figure 2
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    Figure 2

    Percentage of participants attaining 5% weight loss from baseline by intervention group over 24 months.

  • Figure 3
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    Figure 3

    Percentage of participants attaining ACSM guideline levels of physical activity by intervention group over 24 months.

    ACSM = American College of Sports Medicine.

Tables

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    Table 1

    Baseline Characteristics of Study Participants

    CharacteristicEnhanced Intervention n = 106Standard Intervention n = 105P Value
    Age, mean (SD), y48.5 (11.9)48.6 (112.1).96
    Weight, mean (SD), kg104.8 (21.6)102.1 (18.7).35
    Body mass index, mean (SD)37.7 (6.5)37.8 (6.7).93
    Waist circumference, mean (SD), cm116.0 (15.1)114.8 (14.1).54
    Physical activity,a mean (SD), min/wk20.3 (26.0)22.1 (28.6).65
    Race/ethnicity, No. (%).44
     White83 (79.0)92 (86.8)
     Hispanic6 (5.7)3 (2.8)
     Black11 (10.5)9 (8.5)
     Other5 (4.8)2 (1.9)
    Education, No. (%).47
     High school or less25 (23.8)23 (22.33)
     Some college31 (29.5)22 (21.35)
     College graduate or other47 (46.7)57 (55.34)
    Female sex, No. (%)79 (75.2)88 (83.0).18
    Household income, No. (%).97
     <$25,00015 (14.3)17 (16.0)
     $25,000–$75,00048 (45.7)47 (44.3)
     >$75,00040 (38.1)39 (36.8)
     Unknown2 (1.9)3 (2.8)
    Employment, No. (%).55
     Full time57 (54.3)64 (60.4)
     Part time25 (23.8)17 (16.0)
     Not employed22 (21.0)24 (22.6)
     Don’t know1 (0.9)1 (0.9)
    Medical Conditions, No. (%)
     Hypertension50 (47.6)54 (50.9).68
     Diabetes15 (14.3)20 (18.9).46
     Dyslipidemia47 (44.8)41 (38.7).40
     Osteoarthritis17 (16.2)16 (15.1).86
     Congenital heart disease3 (2.9)3 (2.8).99
    • ↵a Minutes of moderate and vigorous physical activity per week.

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    Table 2

    Change from Baseline in Weight and Minutes of Moderate and Vigorous Physical Activity per Week Over 24 Months

    Study VisitWeight, Average (95% CI), kgPhysical Activity, Average (95% CI), min/wk
    EI GroupSI GroupEI GroupSI Group
    Baseline103.8 (99.8 to 107.8)102.8 (98.8 to 106.8)20.6 (0.0 to 44.4)23.0 (0.0 to 46.7)
    6 Mo−5.0 (−6.4 to −3.5)−3.4 (−4.9 to −1.9)95.7 (71.9 to 119.4)67.9 (44.2 to 91.6)
    12 Mo−5.4 (−6.9 to −3.9)−3.8 (−5.3 to −2.3)126.1 (102.3 to 149.8)73.3 (49.6 to 97.0)
    18 Mo−4.4 (−5.9 to −2.9)−4.3 (−5.8 to −2.8)103.6 (80.0 to 127.5)63.3 (39.6 to 87.0)
    24 Mo−4.1 (−5.6 to −2.6)−4.0 (−5.5 to −2.5)101.3 (77.6 to 127.4)75.0 (51.3 to 98.7)
    Group by Visit Interaction
    F ratioF3,620 = 3.17a; P = .02F4,832 = 2.49b; P = .04
    • EI = enhanced intervention; SI = standard intervention.

    • Note: Weight at baseline is actual weight; weights at 6, 12, 18, and 24 months are weight changes from baseline.

    • ↵a Interaction F statistic for change in weight; model adjusted for age, sex, and race/ethnicity.

    • ↵b Interaction F statistic for physical activity minutes; model adjusted for age, sex, and race/ethnicity.

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    Table 3

    Adherence to Behavioral Intervention, by Intervention Group

    Type of ContactEnhanced InterventionStandard Intervention
    Per ProtocolAverage ActualPer ProtocolAverage Actual
    Lifestyle counselor, face-to-face counseling, year 132.732.8
    Lifestyle counselor, telephone calls, year 187——
    Food and exercise journals——
    Journals completed2414——
    Weekly weights recorded2412——
    Fat grams recorded2411——
    Physical activity recorded2410.5——
    Tailored mailings
    Nutrition reports, year 143.2——
    Physical activity reports, year 1135.9——
    Physical activity reports, year 241.4——

Additional Files

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    Supplemental appendixes in pdf.

    Files in this Data Supplement:

    • Supplemental data: Appendixes - PDF file
  • The Article in Brief

    A Randomized Clinical Trial of a Tailored Lifestyle Intervention for Obese, Sedentary, Primary Care Patients

    Charles B. Eaton , and colleagues

    Background Tailored interventions that match individual patient characteristics with treatment may help patients lose weight and increase physical activity. Such programs implemented by print, telephone, and/or video, without extensive face-to-face counseling, may be an effective model for primary care patients. This study uses weekly telephone counseling calls, individually tailored educational materials and DVDs focused on diet and physical activity over the first year, with a tapered maintenance phase during the second year.

    What This Study Found A home-based weight loss and physical activity intervention for obese, sedentary adult primary care patients is effective in promoting weight loss and increasing physical activity, with effects peaking at 12 months but waning at 24 months. In this study, by the end of the active treatment phase, almost half of the enhanced intervention group lost more than 5 percent of baseline weight � a clinically significant amount � and one-third maintained the loss at 24 months. The enhanced intervention group also reported significantly more minutes of moderate to vigorous physical activity over time than the standard intervention group. Similar trends were found for absolute weight loss and the percentage reaching national guidelines for physical activity. Overall, the benefits appear to peak at 12 months for both weight loss and increasing physical activity, with no statistically significant difference in benefit between the groups at 24 months.

    Implications

    • These findings suggest that referral by a primary care physician to a home-based program with limited face-to-face contact can lead to weight loss and increases in moderate to vigorous physical activity.
    • The authors call for research to examine the use of ancillary health care staff or peer counselors in combination with computerized tailoring software, as well as technology such as web e-mails, text messages or smart phone apps, to provide support and tailored content.
  • Annals Journal Club

    Jul/Aug 2016: A Randomized Clinical Trial of a Tailored Lifestyle Intervention for Obese, Sedentary, Primary Care Patients


    The Annals of Family Medicine encourages readers to develop a learning community of those seeking to improve health care and health through enhanced primary care. You can participate by conducting a RADICAL journal club and sharing the results of your discussions in the Annals online discussion for the featured articles. RADICAL is an acronym for Read, Ask, Discuss, Inquire, Collaborate, Act, and Learn. The word radical also indicates the need to engage diverse participants in thinking critically about important issues affecting primary care and then acting on those discussions.1

    HOW IT WORKS

    In each issue, the Annals selects an article or articles and provides discussion tips and questions. We encourage you to take a RADICAL approach to these materials and to post a summary of your conversation in our online discussion. (Open the article online and click on "TRACK Discussion: Submit a comment.") You can find discussion questions and more information online at: http://www.AnnFamMed.org/site/AJC/.

    CURRENT SELECTION

    Article for Discussion

    Eaton CB, Hartman S, Perzanowski E, et al. A randomized clinical trial of a tailored lifestyle intervention for obese, sedentary, primary care patients. Ann Fam Med 2016;14(4):311-319.

    Discussion Tips

    This article provides a chance to consider a pragmatic intervention for one of the country's biggest health problems.

    Discussion Questions

    • What question is asked by this study and why does it matter?
    • Why did the authors choose this lifestyle intervention? How does this intervention differ from other programs for obese, sedentary adults?
    • How appropriate is the block-randomized controlled trial design for answering this question?
    • To what degree can the findings be accounted for by:
      1. How patients were selected, excluded, randomized, and lost to follow-up?
      2. How the main outcome variables were measured or self-reported?
      3. Confounding (false attribution of causality because 2 variables discovered to be associated actually are associated with a 3rd factor)? How do the authors attempt to control for confounding in their analysis?
      4. Chance?
    • What are the main study findings?
    • How do you interpret the differences in outcomes after 6, 12, 18, and 24 months follow-up?
    • How applicable is the study protocol to your practice? Are the study participants similar to your patients? What would be needed to make such an intervention practical in your setting?
    • How could this study change your practice? Policy? Education? Research?
    • If you designed a new lifestyle intervention for obese, sedentary adults in your own practice, how would it be structured and why? What evidence would you have to support its efficacy?
    • What are the next steps in interpreting or applying these findings?
    • What researchable questions remain?

    References

    1. Stange KC, Miller WL, McLellan LA, et al. Annals Journal Club: It's time to get RADICAL. Ann Fam Med. 2006;4(3):196-197 http://annfammed.org/content/4/3/196.full.

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A Randomized Clinical Trial of a Tailored Lifestyle Intervention for Obese, Sedentary, Primary Care Patients
Charles B. Eaton, Sheri J. Hartman, Elizabeth Perzanowski, Guohui Pan, Mary B. Roberts, Patricia M. Risica, Kim M. Gans, John M. Jakicic, Bess H. Marcus
The Annals of Family Medicine Jul 2016, 14 (4) 311-319; DOI: 10.1370/afm.1952

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A Randomized Clinical Trial of a Tailored Lifestyle Intervention for Obese, Sedentary, Primary Care Patients
Charles B. Eaton, Sheri J. Hartman, Elizabeth Perzanowski, Guohui Pan, Mary B. Roberts, Patricia M. Risica, Kim M. Gans, John M. Jakicic, Bess H. Marcus
The Annals of Family Medicine Jul 2016, 14 (4) 311-319; DOI: 10.1370/afm.1952
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