Design of Control‐Group Conditions in Clinical Trials of Behavioral Interventions

Lindquist, Ruth; Wyman, Jean F.; Talley, Kristine Mc; Findorff, Mary J.; Gross, Cynthia R.

doi:10.1111/j.1547-5069.2007.00171.x

Cited by 100 publications

(104 citation statements)

References 38 publications

(39 reference statements)

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“…(Lindquist, Wyman, Talley, Findorff, & Gross, 2007). At the same time, the AC should not affect the outcome of interest (Lindquist et al, 2007); in this case the mothers' breastfeeding behaviors. Therefore, mothers in the AC group were given educational information about infant safety.…”

Section: Controlmentioning

confidence: 96%

Evaluating Motivational Interviewing to Promote Breastfeeding by Rural Mexican-American Mothers: the Challenge of Attrition

Wilhelm

Aguirre²,

Koehler

et al. 2014

Issues in Comprehensive Pediatric Nursing

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Although most Hispanic/Latino-American mothers initiate breastfeeding, duration and exclusivity of breastfeeding remain low. We explored whether a motivational interviewing (MI) intervention could help rural Mexican-American mothers continue breastfeeding. We used a two-group (MI intervention n = 26, attention control [AC] n = 27) repeated measures experimental design. Assessments and interventions occurred at 3 days, 2 weeks, and 6 weeks postpartum (time points when mothers are particularly vulnerable to discontinuing breastfeeding), with a final phone assessment at 6 months postpartum. We collected demographic data and measured intent to breastfeed for 6 months (intent question), self-efficacy (Breastfeeding Self-Efficacy Scale-Short Form), and collected breastfeeding information (breastfeeding assessment questionnaire). Independent t-tests and Mann Whitney U non-parametric tests were used to evaluate group differences (α = 0.05). High levels of attrition by week 6 impaired our ability to evaluate the potential of our MI intervention. No significant differences were found between groups for any of the outcome variables (intent to breastfeed for 6 months, breastfeeding self-efficacy, and duration of breastfeeding). Though the mothers intended to breastfeed for 6 months and were confident in their ability to do so, most did not breastfeed for 6 months. At 6 months, mothers receiving the MI intervention had breastfed an average of 90 days compared to 82 days for those receiving the AC sessions and 22% of the mothers in each group were still breastfeeding at some level. Because of the impact of attrition during this study, we discuss factors that contributed to attrition and approaches to lessen this problem in future studies. Such efforts may require a greater investment of time and resources and should be budgeted accordingly. Culturally appropriate interventions are needed to help rural Mexican-American mothers meet their breastfeeding goals, thus providing an opportunity to reduce their children's risk of multiple diseases and obesity. Only when we address these considerations will we have an opportunity to decrease health disparities, promote healthy behaviors, and be trusted health care partners.

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Section: Controlmentioning

confidence: 96%

Evaluating Motivational Interviewing to Promote Breastfeeding by Rural Mexican-American Mothers: the Challenge of Attrition

Wilhelm

Aguirre²,

Koehler

et al. 2014

Issues in Comprehensive Pediatric Nursing

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“…The methods used in this study have been described elsewhere. 40,41 Only data on the participants randomized to the fall prevention program are included in this analysis because that group received exercise adoption instruction. Participants were recruited through letters mailed to a population-based sample of female Medicare enrollees.…”

Section: Design and Samplementioning

confidence: 99%

Predictors of Long-term Exercise Adherence in a Community-Based Sample of Older Women

Findorff

Wyman

Gross

2009

Journal of Women's Health

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Background: Few studies have examined long-term exercise adherence in older women. The purpose of this study was to assess predictors of adherence to an intervention involving walking and balance exercises. Methods: This was a randomized controlled trial with 2-year follow-up. Sedentary women (n ¼ 137) aged !70 randomized to the exercise intervention were evaluated in their homes. The exercise prescription included walking 30 minutes per day 5 days per week and completing 11 balance exercises twice per week. The main outcome measure was exercise adherence of the intervention group only. Results: The average number of minutes walked per week was 95.2 (SD 68.8); 17% walked the recommended 150 minutes or greater. The average number of times the balance exercises were done was 1.5 (SD 1.6) per week. Results of regression analysis for walking adherence showed clinical variables accounted for the greatest variance (17%) of all the blocks, and cognitive variables were second highest (12%). The final model explained 19% of the variance in predicting adherence to walking. Results of regression analysis for adherence to balance exercises showed health-related quality of life (HRQOL) variables accounted for the greatest variance (14%), followed by cognitive variables (12%). The final model explained 24% of the variance in predicting adherence to balance exercises. Conclusions: Adherence to exercise was below recommended goals, although this study demonstrated that sedentary women can adopt and continue regular exercise long term. Predictors of adherence varied with different forms of exercise. Individually tailored exercise interventions may be most amenable to older women.

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“…In order to control for attention, subjects randomized to group A and B also receive a weekly data assessment message; however, these messages are not tailored to the individual subject. 33 The study events schedule is listed in Table I.…”

Section: Group Descriptionsmentioning

confidence: 99%

Rationale and design of the Investigation of Motivational Interviewing and Prevention Consults to Achieve Cardiovascular Targets (IMPACT) trial

Gianos

Schoenthaler

Mushailov

et al. 2015

American Heart Journal

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Design of Control‐Group Conditions in Clinical Trials of Behavioral Interventions

Abstract: Pitfalls in the design of behavioral intervention studies may be avoided with the application of sound design principles. The FEPP active control condition can be used as a model in the design of future studies.

Cited by 100 publications

References 38 publications

Evaluating Motivational Interviewing to Promote Breastfeeding by Rural Mexican-American Mothers: the Challenge of Attrition

Evaluating Motivational Interviewing to Promote Breastfeeding by Rural Mexican-American Mothers: the Challenge of Attrition

Predictors of Long-term Exercise Adherence in a Community-Based Sample of Older Women

Rationale and design of the Investigation of Motivational Interviewing and Prevention Consults to Achieve Cardiovascular Targets (IMPACT) trial

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