Feasibility and acceptability of a multiple risk factor intervention: The Step Up randomized pilot trial

Jennifer B. McClure, Sheryl L Catz, Evette J. Ludman, Julie Richards, Karin Riggs, Lou Grothaus

Research output: Contribution to journalArticle

11 Citations (Scopus)

Abstract

Background: Interventions are needed which can successfully modify more than one disease risk factor at a time, but much remains to be learned about the acceptability, feasibility, and effectiveness of multiple risk factor (MRF) interventions. To address these issues and inform future intervention development, we conducted a randomized pilot trial (n = 52). This study was designed to assess the feasibility and acceptability of the Step Up program, a MRF cognitive-behavioral program designed to improve participants' mental and physical well-being by reducing depressive symptoms, promoting smoking cessation, and increasing physical activity. Methods. Participants were recruited from a large health care organization and randomized to receive usual care treatment for depression, smoking, and physical activity promotion or the phone-based Step Up counseling program plus usual care. Participants were assessed at baseline, three and six months. Results: The intervention was acceptable to participants and feasible to offer within a healthcare system. The pilot also offered important insights into the optimal design of a MRF program. While not powered to detect clinically significant outcomes, changes in target behaviors indicated positive trends at six month follow-up and statistically significant improvement was also observed for depression. Significantly more experimental participants reported a clinically significant improvement (50% reduction) in their baseline depression score at four months (54% vs. 26%, OR = 3.35, 95% CI [1.01- 12.10], p = 0.05) and 6 months (52% vs. 13%, OR = 7.27, 95% CI [1.85 - 37.30], p = 0.004). Conclusions: Overall, results suggest the Step Up program warrants additional research, although some program enhancements may be beneficial. Key lessons learned from this research are shared to promote the understanding of others working in this field. Trial registration. The trial is registered with ClinicalTrials.gov (NCT00644995).

Original languageEnglish (US)
Article number167
JournalBMC Public Health
Volume11
DOIs
StatePublished - 2011
Externally publishedYes

Fingerprint

Depression
Delivery of Health Care
Smoking Cessation
Research
Counseling
Smoking

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health

Cite this

Feasibility and acceptability of a multiple risk factor intervention : The Step Up randomized pilot trial. / McClure, Jennifer B.; Catz, Sheryl L; Ludman, Evette J.; Richards, Julie; Riggs, Karin; Grothaus, Lou.

In: BMC Public Health, Vol. 11, 167, 2011.

Research output: Contribution to journalArticle

McClure, Jennifer B. ; Catz, Sheryl L ; Ludman, Evette J. ; Richards, Julie ; Riggs, Karin ; Grothaus, Lou. / Feasibility and acceptability of a multiple risk factor intervention : The Step Up randomized pilot trial. In: BMC Public Health. 2011 ; Vol. 11.
@article{3aeaa785bf9e440587dbb34013c739ea,
title = "Feasibility and acceptability of a multiple risk factor intervention: The Step Up randomized pilot trial",
abstract = "Background: Interventions are needed which can successfully modify more than one disease risk factor at a time, but much remains to be learned about the acceptability, feasibility, and effectiveness of multiple risk factor (MRF) interventions. To address these issues and inform future intervention development, we conducted a randomized pilot trial (n = 52). This study was designed to assess the feasibility and acceptability of the Step Up program, a MRF cognitive-behavioral program designed to improve participants' mental and physical well-being by reducing depressive symptoms, promoting smoking cessation, and increasing physical activity. Methods. Participants were recruited from a large health care organization and randomized to receive usual care treatment for depression, smoking, and physical activity promotion or the phone-based Step Up counseling program plus usual care. Participants were assessed at baseline, three and six months. Results: The intervention was acceptable to participants and feasible to offer within a healthcare system. The pilot also offered important insights into the optimal design of a MRF program. While not powered to detect clinically significant outcomes, changes in target behaviors indicated positive trends at six month follow-up and statistically significant improvement was also observed for depression. Significantly more experimental participants reported a clinically significant improvement (50{\%} reduction) in their baseline depression score at four months (54{\%} vs. 26{\%}, OR = 3.35, 95{\%} CI [1.01- 12.10], p = 0.05) and 6 months (52{\%} vs. 13{\%}, OR = 7.27, 95{\%} CI [1.85 - 37.30], p = 0.004). Conclusions: Overall, results suggest the Step Up program warrants additional research, although some program enhancements may be beneficial. Key lessons learned from this research are shared to promote the understanding of others working in this field. Trial registration. The trial is registered with ClinicalTrials.gov (NCT00644995).",
author = "McClure, {Jennifer B.} and Catz, {Sheryl L} and Ludman, {Evette J.} and Julie Richards and Karin Riggs and Lou Grothaus",
year = "2011",
doi = "10.1186/1471-2458-11-167",
language = "English (US)",
volume = "11",
journal = "BMC Public Health",
issn = "1471-2458",
publisher = "BioMed Central",

}

TY - JOUR

T1 - Feasibility and acceptability of a multiple risk factor intervention

T2 - The Step Up randomized pilot trial

AU - McClure, Jennifer B.

AU - Catz, Sheryl L

AU - Ludman, Evette J.

AU - Richards, Julie

AU - Riggs, Karin

AU - Grothaus, Lou

PY - 2011

Y1 - 2011

N2 - Background: Interventions are needed which can successfully modify more than one disease risk factor at a time, but much remains to be learned about the acceptability, feasibility, and effectiveness of multiple risk factor (MRF) interventions. To address these issues and inform future intervention development, we conducted a randomized pilot trial (n = 52). This study was designed to assess the feasibility and acceptability of the Step Up program, a MRF cognitive-behavioral program designed to improve participants' mental and physical well-being by reducing depressive symptoms, promoting smoking cessation, and increasing physical activity. Methods. Participants were recruited from a large health care organization and randomized to receive usual care treatment for depression, smoking, and physical activity promotion or the phone-based Step Up counseling program plus usual care. Participants were assessed at baseline, three and six months. Results: The intervention was acceptable to participants and feasible to offer within a healthcare system. The pilot also offered important insights into the optimal design of a MRF program. While not powered to detect clinically significant outcomes, changes in target behaviors indicated positive trends at six month follow-up and statistically significant improvement was also observed for depression. Significantly more experimental participants reported a clinically significant improvement (50% reduction) in their baseline depression score at four months (54% vs. 26%, OR = 3.35, 95% CI [1.01- 12.10], p = 0.05) and 6 months (52% vs. 13%, OR = 7.27, 95% CI [1.85 - 37.30], p = 0.004). Conclusions: Overall, results suggest the Step Up program warrants additional research, although some program enhancements may be beneficial. Key lessons learned from this research are shared to promote the understanding of others working in this field. Trial registration. The trial is registered with ClinicalTrials.gov (NCT00644995).

AB - Background: Interventions are needed which can successfully modify more than one disease risk factor at a time, but much remains to be learned about the acceptability, feasibility, and effectiveness of multiple risk factor (MRF) interventions. To address these issues and inform future intervention development, we conducted a randomized pilot trial (n = 52). This study was designed to assess the feasibility and acceptability of the Step Up program, a MRF cognitive-behavioral program designed to improve participants' mental and physical well-being by reducing depressive symptoms, promoting smoking cessation, and increasing physical activity. Methods. Participants were recruited from a large health care organization and randomized to receive usual care treatment for depression, smoking, and physical activity promotion or the phone-based Step Up counseling program plus usual care. Participants were assessed at baseline, three and six months. Results: The intervention was acceptable to participants and feasible to offer within a healthcare system. The pilot also offered important insights into the optimal design of a MRF program. While not powered to detect clinically significant outcomes, changes in target behaviors indicated positive trends at six month follow-up and statistically significant improvement was also observed for depression. Significantly more experimental participants reported a clinically significant improvement (50% reduction) in their baseline depression score at four months (54% vs. 26%, OR = 3.35, 95% CI [1.01- 12.10], p = 0.05) and 6 months (52% vs. 13%, OR = 7.27, 95% CI [1.85 - 37.30], p = 0.004). Conclusions: Overall, results suggest the Step Up program warrants additional research, although some program enhancements may be beneficial. Key lessons learned from this research are shared to promote the understanding of others working in this field. Trial registration. The trial is registered with ClinicalTrials.gov (NCT00644995).

UR - http://www.scopus.com/inward/record.url?scp=79952698651&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=79952698651&partnerID=8YFLogxK

U2 - 10.1186/1471-2458-11-167

DO - 10.1186/1471-2458-11-167

M3 - Article

C2 - 21414216

AN - SCOPUS:79952698651

VL - 11

JO - BMC Public Health

JF - BMC Public Health

SN - 1471-2458

M1 - 167

ER -