Effectiveness of a diabetes prevention program for rural women with prior gestational diabetes mellitus: study protocol of a multi-site randomized clinical trial

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Different lines of evidence indicate that knowledge of low-glycemic index (GI) foods and the practice of eating them play important roles in blood glucose management and preventing T2DM in women with prior gestational diabetes mellitus (GDM). According to the theory of planned behavior (TPB), intention is a critical factor in complying with health-related behaviors. However, an instrument for assessing the intention to eat low-GI foods is lacking in China. We aimed to (1) adapt and validate a Chinese version of the intentions to eat low-GI foods questionnaire (CIELQ) and (2) apply the CIELQ among rural Chinese women to explore the associations between CIELQ scores and glycemic status. A cross-sectional study was conducted on 417 nondiabetic, nonpregnant participants with a history of GDM in Hunan, China. After cultural adaptation and validation, the CIELQ was applied in a target population. Glycemic status, anthropometric variables, dietary intake, and physical activity were measured; a self-developed, standard questionnaire was applied to collect relevant information. The CIELQ showed good internal consistency; model fitness was acceptable based on the confirmatory factor analysis results. Awareness of the glycemic index was low among the study population. TPB factors were found to be associated with each other; education level and parents’ diabetes history were associated with specific factors. The score for instrumental attitude showed a positive association with the risk for a high level of the 2-h 75-g oral glucose tolerance test (odds ratio, OR = 1.330), while the score for perceived behavior control (PBC) showed a negative association with the risk for a high level (OR = 0.793). The CIELQ was determined to be a valid instrument for assessing the intention to eat a low-GI diet among the study population. The awareness of the GI was poor among the study population. The score for instrumental attitude showed a positive association with the risk of a high level on the 2-h 75-g oral glucose tolerance test (OGTT), and the score for PBC showed a negative association with the risk for a high level on OGTT.

Section: Methodsmentioning

confidence: 99%

Cultural Adaptation, Validation, and Primary Application of a Questionnaire to Assess Intentions to Eat Low-Glycemic Index Foods among Rural Chinese Women

Lin

et al. 2020

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“…The multisite randomized clinical trial (RCT) has been reported elsewhere and registered in the Chinese Clinical Trial Registry (ChiCTR) (No. ChiCTR1800015023) [ 24 ]. To represent different socioeconomic status, lifestyle, and ethnic groups in the Hunan Province, two counties were selected as study sites: one county with a less developed economy and a large ethnic minority population and another county with middle to high economic development and a predominately Han population.…”

Section: Methodsmentioning

confidence: 99%

“…The sample size of n = 320 (160 in the intervention group and 160 in the control group) was based on the change in insulin resistance in a previous trial [ 24 ]. For testing hypotheses about the impact of the intervention on QoL measures, we calculated power based on the G*Power 3 option “ANOVA repeated measures for between group (2 groups) by within group (3 times) interactions” based on F-tests [ 24 ]. The null hypothesis is that this interaction is nil and the alternate hypothesis is that the intervention group will show more positive change than the control group.…”

Section: Methodsmentioning

confidence: 99%

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The Efficacy of an Intensive Lifestyle Modification Program on Psychosocial Outcomes among Rural Women with Prior Gestational Diabetes Mellitus: Six Months Follow-Up of a Randomized Controlled Trial

Guo

Long

Yang

et al. 2021

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Women with prior gestational diabetes mellitus (GDM) are at a higher risk of type 2 diabetes and other health issues after delivery. They may have a lower quality of life (QoL), experience more medical-related stress, and need more support than those without it. This study aimed to examine the six-month efficacy of an intensive lifestyle modification program on perceived stress, social support, and QoL among women with prior GDM in rural China. A total of 320 women with prior GDM were randomly assigned to an intervention group (n = 160) and a control group (n = 160). Participants in the intervention group received an intensive lifestyle modification (ILSM) program, including a series of six biweekly face-to-face sessions and five biweekly phone sessions delivered by trained local health workers. The control group received the usual care. Data about perceived stress, social support, QoL, and HbA1c were collected at baseline, at three months, and at six-month follow-ups. Generalized estimating equation analysis was used to assess the efficacy of the intervention. There were significant improvements in the psychological domain (β = 0.479 ± 0.153, p = 0.002) and environmental domain (β = 0.462 ± 0.145, p = 0.001) of QoL over six months; there were significant group effects (β = −0.718 ± 0.280, p = 0.010) and time effects (β = 0.453 ± 0.211, p = 0.032) in physiological domain, and there were significant group effects in the social relations domain (β = −0.669 ± 0.321, p = 0.037). The ILSM group had a more pronounced downward trend in HbA1c than the control group (β = −0.050 ± 0.026, p = 0.059). The ILSM program can help women with GDM improve their psychological and environmental domain of QoL. It can be recommended as a form of health promotion for improving QoL among women with prior GDM in rural primary care settings in developing countries.

“…This study is a baseline survey on the dietary practice of women with a history of GDM. This work is part of a randomized clinical trial (ChiCTR1800015023) that aims to examine the effect of intensive lifestyle modifications on physiological health outcomes (e.g., T2DM development, insulin resistance, and weight-related variables) for women with previous GDM in rural areas [ 18 ]. According to a previous study that applied CHEI to the 2011 China Health and Nutrition Survey, which obtained standard deviations (SDs) of 9.5 among rural residents and 11.3 among female participants [ 12 ], we calculated a sample size of 423 under a hypothesized SD of 10.0, allowance error of 1.0, and drop-out rate of 10% (PASS software version 11.0 for Windows, NCSS LLC, Kaysville, UT, USA).…”

Section: Methodsmentioning

confidence: 99%

Diet Quality among Women with Previous Gestational Diabetes Mellitus in Rural Areas of Hunan Province

Shi

Luo

et al. 2020

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Diet quality is critical for postpartum type 2 diabetes mellitus (T2DM) progression among women with a history of gestational diabetes mellitus (GDM). The Chinese Healthy Eating Index (CHEI) is a dietary index developed according to the latest Chinese Dietary Guidelines (CDG-2016). Our study aimed to assess the diet quality of women with previous GDM in rural areas of Hunan Province by applying the CHEI. Women with previous GDM in two counties of Hunan were enrolled. Their food intake data, which were used to calculate their CHEI scores, were collected by a 24-h dietary recall. The association of CHEI with sociodemographic and anthropometric variables was evaluated via linear regression models. 404 women were included in the final analysis. The mean score of the total CHEI was 54.9 (SD 7.9). The components of whole grains and mixed beans, seeds and nuts, tubers, dairy, and poultry scored extremely low. Ethnic minority groups and women younger than 30 years had lower CHEI scores. Our study observed an unsatisfactory diet quality among women with previous GDM in rural areas of Hunan Province. Future dietary education focusing on the CDG is needed to improve their diet quality and help in T2DM prevention among this population, especially young and ethnic minority women.