Design and methods of a multi-site, multi-behavioral treatment trial for menopausal symptoms: The MsFLASH experience

Barbara Sternfeld; Andrea LaCroix; Bette J. Caan; Andrea L. Dunn; Katherine M. Newton; Susan D. Reed; Katherine A. Guthrie; Cathryn Booth-LaForce; Karen J. Sherman; Lee Cohen; Marlene P. Freeman; Janet S. Carpenter; Julie R. Hunt; Melanie Roberts; Kristine E. Ensrud

doi:10.1016/j.cct.2013.02.009

Design and methods of a multi-site, multi-behavioral treatment trial for menopausal symptoms: The MsFLASH experience

Barbara Sternfeld, Andrea LaCroix, Bette J. Caan, Andrea L. Dunn, Katherine M. Newton, Susan D. Reed, Katherine A. Guthrie, Cathryn Booth-LaForce, Karen J. Sherman, Lee Cohen, Marlene P. Freeman, Janet S. Carpenter, Julie R. Hunt, Melanie Roberts, Kristine E. Ensrud

Medicine - Veteran's Administration Medical Center

Research output: Contribution to journal › Article › peer-review

22 Scopus citations

Abstract

Background: Behavioral strategies are recommended for menopausal symptoms, but little evidence exists regarding efficacy. Purpose: Describe design and methodology of a randomized controlled 3 by 2 factorial trial of yoga, exercise and omega-3 fatty acids. Methods: Women from three geographic areas with a weekly average of ≥ 14 hot flashes/night sweats, who met exclusion/inclusion criteria, were randomized to 12. weeks of: 1) yoga classes and daily home practice; 2) supervised, facility-based aerobic exercise training; or 3) usual activity. Women in each arm were further randomized to either omega-3 supplement or placebo. Standardized training, on-going monitoring, and site visits were adopted to ensure consistency across sites and fidelity to the intervention. Participant adherence to the intervention protocol was monitored continuously, and retention was actively encouraged by staff. Information on adverse events was systematically collected. Results: Of 7377 women who responded to mass mailings, 355 (4.8%) were randomized; mean age was 54.7 (sd=3.7), 26.2% were African American, 81.7% were post-menopausal, and mean baseline frequency of daily hot flashes/night sweats was 7.6 (sd=3.8). Adherence of ≥ 80% was 59% for yoga, 77% for exercise training, and 80% for study pills. Final week 12 data were collected from 95.2%. Conclusions: Conducting a multi-site, multi-behavioral randomized trial for menopausal symptoms is challenging but feasible. Benefits included cost-effective study design, centralized recruitment, and methodologic standardization.

Original language	English (US)
Pages (from-to)	25-34
Number of pages	10
Journal	Contemporary Clinical Trials
Volume	35
Issue number	1
DOIs	https://doi.org/10.1016/j.cct.2013.02.009
State	Published - May 2013

Bibliographical note

Funding Information:
This study was supported by a cooperative agreement issued by the National Institute of Aging (NIA) , in collaboration with the Eunice Kennedy Shriver National Institute of Child Health and Development (NICHD), the National Center for Complementary and Alternative Medicine (NCCAM) and the Office of Research and Women's Health (ORWH), and grants U01 AG032656 , U01AG032659 , U01AG032669 , U01AG032682 , U01AG032699 , U01AG032700 from the NIA. At the Indiana University site, the project was funded in part with support from the Indiana Clinical and Translational Sciences Institute , funded in part by grant UL1 RR025761 from the National Institutes of Health, National Center for Research Resources, Clinical and Translational Sciences Award .

Funding Information:
Drs. Newton and Reed reported research support from Otsuka Pharmaceutical Co., Ltd.

Keywords

Exercise
Factorial design
Omega-3 fatty acids
Randomized controlled trial
Vasomotor symptoms
Yoga

Publisher link

10.1016/j.cct.2013.02.009

Find It

Find It at U of M Libraries

Cite this

Sternfeld, B., LaCroix, A., Caan, B. J., Dunn, A. L., Newton, K. M., Reed, S. D., Guthrie, K. A., Booth-LaForce, C., Sherman, K. J., Cohen, L., Freeman, M. P., Carpenter, J. S., Hunt, J. R., Roberts, M., & Ensrud, K. E. (2013). Design and methods of a multi-site, multi-behavioral treatment trial for menopausal symptoms: The MsFLASH experience. Contemporary Clinical Trials, 35(1), 25-34. https://doi.org/10.1016/j.cct.2013.02.009

Sternfeld, B, LaCroix, A, Caan, BJ, Dunn, AL, Newton, KM, Reed, SD, Guthrie, KA, Booth-LaForce, C, Sherman, KJ, Cohen, L, Freeman, MP, Carpenter, JS, Hunt, JR, Roberts, M & Ensrud, KE 2013, 'Design and methods of a multi-site, multi-behavioral treatment trial for menopausal symptoms: The MsFLASH experience', Contemporary Clinical Trials, vol. 35, no. 1, pp. 25-34. https://doi.org/10.1016/j.cct.2013.02.009

@article{879f6b2359504d0c9f4bad995447018f,

title = "Design and methods of a multi-site, multi-behavioral treatment trial for menopausal symptoms: The MsFLASH experience",

abstract = "Background: Behavioral strategies are recommended for menopausal symptoms, but little evidence exists regarding efficacy. Purpose: Describe design and methodology of a randomized controlled 3 by 2 factorial trial of yoga, exercise and omega-3 fatty acids. Methods: Women from three geographic areas with a weekly average of ≥ 14 hot flashes/night sweats, who met exclusion/inclusion criteria, were randomized to 12. weeks of: 1) yoga classes and daily home practice; 2) supervised, facility-based aerobic exercise training; or 3) usual activity. Women in each arm were further randomized to either omega-3 supplement or placebo. Standardized training, on-going monitoring, and site visits were adopted to ensure consistency across sites and fidelity to the intervention. Participant adherence to the intervention protocol was monitored continuously, and retention was actively encouraged by staff. Information on adverse events was systematically collected. Results: Of 7377 women who responded to mass mailings, 355 (4.8%) were randomized; mean age was 54.7 (sd=3.7), 26.2% were African American, 81.7% were post-menopausal, and mean baseline frequency of daily hot flashes/night sweats was 7.6 (sd=3.8). Adherence of ≥ 80% was 59% for yoga, 77% for exercise training, and 80% for study pills. Final week 12 data were collected from 95.2%. Conclusions: Conducting a multi-site, multi-behavioral randomized trial for menopausal symptoms is challenging but feasible. Benefits included cost-effective study design, centralized recruitment, and methodologic standardization.",

keywords = "Exercise, Factorial design, Omega-3 fatty acids, Randomized controlled trial, Vasomotor symptoms, Yoga",

author = "Barbara Sternfeld and Andrea LaCroix and Caan, {Bette J.} and Dunn, {Andrea L.} and Newton, {Katherine M.} and Reed, {Susan D.} and Guthrie, {Katherine A.} and Cathryn Booth-LaForce and Sherman, {Karen J.} and Lee Cohen and Freeman, {Marlene P.} and Carpenter, {Janet S.} and Hunt, {Julie R.} and Melanie Roberts and Ensrud, {Kristine E.}",

note = "Funding Information: This study was supported by a cooperative agreement issued by the National Institute of Aging (NIA) , in collaboration with the Eunice Kennedy Shriver National Institute of Child Health and Development (NICHD), the National Center for Complementary and Alternative Medicine (NCCAM) and the Office of Research and Women's Health (ORWH), and grants U01 AG032656 , U01AG032659 , U01AG032669 , U01AG032682 , U01AG032699 , U01AG032700 from the NIA. At the Indiana University site, the project was funded in part with support from the Indiana Clinical and Translational Sciences Institute , funded in part by grant UL1 RR025761 from the National Institutes of Health, National Center for Research Resources, Clinical and Translational Sciences Award . Funding Information: Drs. Newton and Reed reported research support from Otsuka Pharmaceutical Co., Ltd. ",

year = "2013",

month = may,

doi = "10.1016/j.cct.2013.02.009",

language = "English (US)",

volume = "35",

pages = "25--34",

journal = "Contemporary Clinical Trials",

issn = "1551-7144",

publisher = "Elsevier Inc.",

number = "1",

}

TY - JOUR

T1 - Design and methods of a multi-site, multi-behavioral treatment trial for menopausal symptoms

T2 - The MsFLASH experience

AU - Sternfeld, Barbara

AU - LaCroix, Andrea

AU - Caan, Bette J.

AU - Dunn, Andrea L.

AU - Newton, Katherine M.

AU - Reed, Susan D.

AU - Guthrie, Katherine A.

AU - Booth-LaForce, Cathryn

AU - Sherman, Karen J.

AU - Cohen, Lee

AU - Freeman, Marlene P.

AU - Carpenter, Janet S.

AU - Hunt, Julie R.

AU - Roberts, Melanie

AU - Ensrud, Kristine E.

N1 - Funding Information: This study was supported by a cooperative agreement issued by the National Institute of Aging (NIA) , in collaboration with the Eunice Kennedy Shriver National Institute of Child Health and Development (NICHD), the National Center for Complementary and Alternative Medicine (NCCAM) and the Office of Research and Women's Health (ORWH), and grants U01 AG032656 , U01AG032659 , U01AG032669 , U01AG032682 , U01AG032699 , U01AG032700 from the NIA. At the Indiana University site, the project was funded in part with support from the Indiana Clinical and Translational Sciences Institute , funded in part by grant UL1 RR025761 from the National Institutes of Health, National Center for Research Resources, Clinical and Translational Sciences Award . Funding Information: Drs. Newton and Reed reported research support from Otsuka Pharmaceutical Co., Ltd.

PY - 2013/5

Y1 - 2013/5

N2 - Background: Behavioral strategies are recommended for menopausal symptoms, but little evidence exists regarding efficacy. Purpose: Describe design and methodology of a randomized controlled 3 by 2 factorial trial of yoga, exercise and omega-3 fatty acids. Methods: Women from three geographic areas with a weekly average of ≥ 14 hot flashes/night sweats, who met exclusion/inclusion criteria, were randomized to 12. weeks of: 1) yoga classes and daily home practice; 2) supervised, facility-based aerobic exercise training; or 3) usual activity. Women in each arm were further randomized to either omega-3 supplement or placebo. Standardized training, on-going monitoring, and site visits were adopted to ensure consistency across sites and fidelity to the intervention. Participant adherence to the intervention protocol was monitored continuously, and retention was actively encouraged by staff. Information on adverse events was systematically collected. Results: Of 7377 women who responded to mass mailings, 355 (4.8%) were randomized; mean age was 54.7 (sd=3.7), 26.2% were African American, 81.7% were post-menopausal, and mean baseline frequency of daily hot flashes/night sweats was 7.6 (sd=3.8). Adherence of ≥ 80% was 59% for yoga, 77% for exercise training, and 80% for study pills. Final week 12 data were collected from 95.2%. Conclusions: Conducting a multi-site, multi-behavioral randomized trial for menopausal symptoms is challenging but feasible. Benefits included cost-effective study design, centralized recruitment, and methodologic standardization.

AB - Background: Behavioral strategies are recommended for menopausal symptoms, but little evidence exists regarding efficacy. Purpose: Describe design and methodology of a randomized controlled 3 by 2 factorial trial of yoga, exercise and omega-3 fatty acids. Methods: Women from three geographic areas with a weekly average of ≥ 14 hot flashes/night sweats, who met exclusion/inclusion criteria, were randomized to 12. weeks of: 1) yoga classes and daily home practice; 2) supervised, facility-based aerobic exercise training; or 3) usual activity. Women in each arm were further randomized to either omega-3 supplement or placebo. Standardized training, on-going monitoring, and site visits were adopted to ensure consistency across sites and fidelity to the intervention. Participant adherence to the intervention protocol was monitored continuously, and retention was actively encouraged by staff. Information on adverse events was systematically collected. Results: Of 7377 women who responded to mass mailings, 355 (4.8%) were randomized; mean age was 54.7 (sd=3.7), 26.2% were African American, 81.7% were post-menopausal, and mean baseline frequency of daily hot flashes/night sweats was 7.6 (sd=3.8). Adherence of ≥ 80% was 59% for yoga, 77% for exercise training, and 80% for study pills. Final week 12 data were collected from 95.2%. Conclusions: Conducting a multi-site, multi-behavioral randomized trial for menopausal symptoms is challenging but feasible. Benefits included cost-effective study design, centralized recruitment, and methodologic standardization.

KW - Exercise

KW - Factorial design

KW - Omega-3 fatty acids

KW - Randomized controlled trial

KW - Vasomotor symptoms

KW - Yoga

UR - http://www.scopus.com/inward/record.url?scp=84875276369&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84875276369&partnerID=8YFLogxK

U2 - 10.1016/j.cct.2013.02.009

DO - 10.1016/j.cct.2013.02.009

M3 - Article

C2 - 23462342

AN - SCOPUS:84875276369

SN - 1551-7144

VL - 35

SP - 25

EP - 34

JO - Contemporary Clinical Trials

JF - Contemporary Clinical Trials

IS - 1

ER -

Design and methods of a multi-site, multi-behavioral treatment trial for menopausal symptoms: The MsFLASH experience

Abstract

Bibliographical note

Keywords

Publisher link

Find It

Other files and links

Fingerprint

Cite this