Randomized Comparative Effectiveness Trial of 2 Federally Recommended Strategies to Reduce Excess Body Fat in Overweight, Low-Income Patients: MyPlate.gov vs Calorie Counting

William J. McCarthy; Melvin Rico; Maria Chandler; Dena R. Herman; Cindy Chang; Thomas R. Belin; Stephanie Love; Evangelina Ramirez; Lillian Gelberg

doi:10.1370/afm.2964

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Figure 1.
CONSORT flow diagram showing reasons for study attrition.
CONSORT = Consolidated Standards of Reporting Trials.

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Table 1.

Baseline Marginal Means for Primary Outcome Measures, by Condition, Among 261 Adult Low-Income Primary Care Patients of a Partnering Federally Qualified Health Center

Outcome Measure	MyPlate	Calorie Counting	Group Difference P Value
Outcome Measure	Baseline Mean (SE)	Baseline Mean (SE)	Group Difference P Value
Hunger, mm	47.09 (2.16)	50.75 (2.17)	.30
Meal satisfaction, mm	66.91 (2.54)	69.31 (2.55)	.54
Feeling full, mm	65.96 (2.31)	69.89 (2.32)	.26
Waist circumference, cm	100.47 (0.81)	103.30 (0.81)	.054
Body weight, kg	80.85 (0.99)	83.03 (1.00)	.31

DASH = Dietary Approaches to Stop Hypertension.
Note: Mean values reflect statistical adjustments for participant age, sex, marital status, educational attainment, race/ethnicity, and DASH score.

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Table 2.

Marginal Mean Differences From Baseline to 6 and 12 Months Follow-Up for Primary Outcome Measures, by Condition, Among 261 Adult Low-Income Primary Care Patients of a Partnering Federally Qualified Health Center

Measure	MyPlate			Calorie Counting			Group Difference^{^b}	Group Difference P Value
Measure	6 Months (95% CI)	12 Months (95% CI)	12-Months Difference P Value	6 Months (95% CI)	12 Months (95% CI)	12-Month Difference P Value	Group Difference^{^b}	Group Difference P Value
Hunger, mm	−3.76 (−9.41 to 1.89)	−6.17 (−11.85 to −0.50)^{^a}	.03^{^a}	−8.29 (−14.22 to −2.36)^{^a}	−9.64 (−15.41 to −3.87)^{^a}	.001^{^a}	−3.47	.51
Meal satisfaction, mm	12.05 (5.01 to 19.09)^{^a}	17.13 (10.07 to 24.20)^{^a}	<.001^{^a}	9.46 (2.09 to 16.83)^{^a}	12.80 (5.62 to 20.0)^{^a}	<.001^{^a}	2.59	.69
Feeling full after meal, mm	5.81 (−0.68 to 12.30)	12.64 (6.12 to 19.15)^{^a}	.001^{^a}	4.89 (−1.90 to 11.68)	8.13 (1.51 to 14.75)^{^a}	.016^{^a}	4.51	.61
Waist circumference, cm^{^c}	−1.42 (−2.75 to −0.08)^{^a}	−1.86 (−3.26 to −0.46)^{^a}	.009^{^a}	−0.39 (−1.82 to 1.04)	−1.71 (−3.16 to −0.26)^{^a}	.02^{^a}	−0.15	.54
Waist circumference, cm^{^d}	−2.18 (−3.50 to −0.85)^{^a}	−3.15 (−4.54 to −1.77)^{^a}	<.001^{^a}	−0.94 (−2.36 to 0.47)	−2.72 (−4.16 to −1.29)^{^a}	.0002^{^a}	−0.43	.45
Body weight, kg	−0.23 (−1.11 to 0.66)	−0.34 (−1.27 to 0.59)	.48	−0.55 (−1.50 to 0.41)	−0.75 (−1.72 to 0.23)	.13	0.41	.81

Note: Mean values reflect statistical adjustments for participant age, sex, marital status, educational attainment, and race/ethnicity. Changes in outcomes observed for participants who participated in 7-11 sessions were greater than changes observed for participants who participated in ≤6 sessions.
↵a Significant change from baseline at the P < .025 for body composition measures (Bonferroni-corrected nominal P value) and at the q =.05 (false-discovery rate) correction for multiplicity of hypothesis testing for the 3 satiety measures.
↵b Group-by-time interaction (group difference in differences from baseline to 12 months follow-up).
↵c Waist circumference not corrected for variation in measurement over clothing.
↵d Waist circumference corrected for variation in measurement over clothing.