Effect of a dietary and exercise intervention in women with overweight and obesity undergoing fertility treatments: Protocol for a randomized controlled trial

Authors: FAWCETT, KINDANN - Arkansas Children'S Nutrition Research Center (ACNC); MARTINEZ, AUDREY - Arkansas Children'S Nutrition Research Center (ACNC); CRIMMINS, MEGHAN - Arkansas Children'S Nutrition Research Center (ACNC); SIMS, CLARK - Arkansas Children'S Nutrition Research Center (ACNC); BORSHEIM, ELISABET - University Arkansas For Medical Sciences (UAMS); ANDRES, ALINE - University Arkansas For Medical Sciences (UAMS)

Submitted to: BMC Nutrition
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 7/6/2021
Publication Date: 8/17/2021
Citation: Fawcett, K., Martinez, A., Crimmins, M., Sims, C., Borsheim, E., Andres, A. 2021. Effect of a dietary and exercise intervention in women with overweight and obesity undergoing fertility treatments: Protocol for a randomized controlled trial. Biomed Central (BMC) Nutrition. 7:51. https://doi.org/10.1186/s40795-021-00454-y.
DOI: https://doi.org/10.1186/s40795-021-00454-y

Interpretive Summary: There are distinct differences between women with obesity and those of normal weight. This study aims to assess the ease and ability of a nutrition and exercise intervention to decrease obesity-associated changes in women's eggs and surrounding fluid, which may benefit their offspring long term. The proposed study will include 120 women with overweight and obesity, who are 21 years of age or older, and are planning to undergo in vitro fertility (IVF) treatments. Participants will be randomized (like flipping a coin) into either a standard of care (N=60) or an intervention group (N=60), with equal amounts of women with polycystic ovary syndrome in these groups. The intervention will combine a provided Mediterranean-style meal plan with prescribed exercise (150-180 minutes of weekly physical activity and daily walking). Participants will be evaluated before and after the intervention, which will complete 2 weeks after the participant's implantation protocol. The group that did not receive the intervention may join the intervention group if the IVF treatments are unsuccessful and will be repeated. The primary objective is to evaluate whether a combined dietary and exercise intervention has an effect on how genes are turned on and off in the women's egg and on the content of the fluid surrounding the egg.

Technical Abstract: Distinct molecular, inflammatory, and metabolic signatures are present in oocyte and follicular fluid derived from women with obesity when compared to those derived from normal weight women, which suggest existing signals that may program future offspring for metabolic diseases. This study aims to assess the feasibility and efficacy of a peri-conception nutrition and exercise intervention on mitigating obesity-associated changes in oocyte gene expression profiles and follicular fluid metabolites. This single blinded randomized control trial will include 120 women with a BMI of 25 – 45 kg/m2, >=21 years of age, and undergoing in vitro fertility (IVF) treatments. Participants will be randomized to standard of care (N=60) or an intervention group (N=60) in a block design by polycystic ovary syndrome status. The intervention will combine a dietary component (Mediterranean meal plan) with a physical activity component intended to engage participant 3 times per week for 50 minutes. Participants will be assessed pre- and post-intervention, which will be completed 2 weeks following the implantation protocol. The standard of care group will be offered to join the intervention group if the IVF treatments are unsuccessful as a cross over design. Primary outcomes will include single oocyte gene expression profiles, follicular fluid metabolites, and acceptability of the intervention. Mann-Whitney U nonparametric tests will be used to assess potential differences for each strata, follicular fluid and serum metabolites will be analyzed using a one-factor ANOVA at four levels, pair-wise comparisons using Tukey-Kramer post-hoc tests will be used to identify groups whose means differ significantly while retaining the family-wise error rate at 5%. Two-way ANOVA or non-parametric Friedman test will be used in data analysis. Significance will be set at p<0.05 for the Spearman Rank Order for non-parametric tests. This study will provide data and key information on the impact of a combination of a dietary and exercise intervention on oocyte gene expression and follicular fluid content.