A Randomized Controlled Feasibility Trial in Behavioral Weight Management for Underserved Postpartum African American Women: The RENEW Study

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Assessed for eligibility were 4,710 women. Excluded were 4,582 women: 3,204 did not meet inclusion criteria; 137 declined to participate, and 1,241 were excluded for other reasons. One hundred twenty-eight women consented to participate in the study. Nineteen women were lost to follow-up between consent and visit 1; 109 women completed Visit 1. Forty-four women were lost to follow-up during pregnancy between visit 1 and visit 2. Sixty-five women completed visit 2; 3 women were then excluded for postpartum depression. Sixty-two women were randomized to the intervention arm or the usual-care arm. Thirty-two women were allocated to the intervention, and 30 were allocated to the usual-care group. Sixteen women in the intervention arm were lost to follow-up for unknown reasons; 10 women in the usual-care arm were lost to follow-up for unknown reasons, and 1 woman withdrew consent because of a lack of time. In the intervention arm, data from 16 women were analyzed. Data from 19 women in the usual-care arm were analyzed.

Figure.
CONSORT diagram of the progress through the phases of a randomized controlled feasibility trial in behavioral weight management for underserved postpartum African American women, Boston, Massachusetts, 2011–2013.

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