|Year : 2022 | Volume
| Issue : 1 | Page : 57-66
Development and validation of comprehensive evaluation tool for weight management at menopausal transition and early menopause stage
Archana Kumari1, Sakshi Chopra2, Piyush Ranjan3, Aditi Verma2, Anita Malhotra4, Ashish Datt Upadhyay5, K Aparna Sharma1, Naval K Vikram3
1 Department of Gynaecology and Obstetrics, All India Institute of Medical Sciences, New Delhi, India
2 Department of Home Science, University of Delhi, New Delhi, India
3 Department of Medicine, All India Institute of Medical Sciences, New Delhi, India
4 Department of Home Science, Lakshmibai College, University of Delhi, New Delhi, India
5 Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India
|Date of Submission||08-Oct-2021|
|Date of Decision||27-Jan-2022|
|Date of Acceptance||01-Feb-2022|
|Date of Web Publication||2-May-2022|
Department of Medicine, All India Institute of Medical Sciences, Ansari Nagar, New Delhi - 110 029
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Objective: To develop and validate a comprehensive questionnaire to evaluate risk factors, perceptions, and practices for weight management in women at menopausal transition and early menopause stage. Methodology: A mixed-method study was conducted in two phases. In the first phase, the questionnaire was developed by literature review and focused group discussions with the target population and experts. In the second phase, content and face validity were established by expert evaluation and cognitive interviews with the target population. The developed questionnaire was crosssectionally administered in 215 women and responses were used to determine the construct validity by factor analysis and reliability by evaluating internal consistency. Results: The finalized questionnaire consisted of two sections; section A included sociodemographic characteristics, anthropometric measures, and menopausal status with symptom severity, while section B contained 32-items focusing on readiness to initiate weight loss, perceptions and practices related to lifestyle behaviors, built environment, and social support. The Cronbach's α value of the questionnaire is 0.79 with good internal consistency. Conclusion: The developed questionnaire is a valid and reliable tool to assess weight-related risk factors, perceptions, and practices in middle-aged women, which can potentially be used by doctors and other healthcare practitioners to customize weight management advice in women at menopausal transition and early menopause.
Keywords: Menopausal transition, obesity, questionnaire, risk factors, weight management
|How to cite this article:|
Kumari A, Chopra S, Ranjan P, Verma A, Malhotra A, Upadhyay AD, Sharma K A, Vikram NK. Development and validation of comprehensive evaluation tool for weight management at menopausal transition and early menopause stage. J Mid-life Health 2022;13:57-66
|How to cite this URL:|
Kumari A, Chopra S, Ranjan P, Verma A, Malhotra A, Upadhyay AD, Sharma K A, Vikram NK. Development and validation of comprehensive evaluation tool for weight management at menopausal transition and early menopause stage. J Mid-life Health [serial online] 2022 [cited 2022 May 18];13:57-66. Available from: https://www.jmidlifehealth.org/text.asp?2022/13/1/57/344565
| Introduction|| |
Weight management among midlife women is vital to maintain menopausal, metabolic, musculoskeletal, and mental health. These women consult doctors of different specialties such as family physicians, gynecologists, internists, or orthopedics for several other health-related issues faced in their day-to-day life, where they first encounter supplementary weight management advice., Often, this weight-related advice is generic and rarely addresses the interplay of several midlife-related risk factors such as aging, menopausal symptoms, emotional volatility, low motivation, competing responsibilities, and lack of social support to meet the desirable weight loss outcome. Evidence suggests that an in-depth understanding of etiological factors through initial assessment is an imperative step for recommending sustainable weight management advice in midlife women. Among these factors, menopausal health and current lifestyle practices such as eating, exercise, and sleep patterns are factors of prime concern for recommending women-centric advice to manage weight in midlife. In current literature, multiple assessment methods such as self-developed questionnaires, comprehensive lists of valid questionnaires, and/or recall methods have been used to assess the contribution of menopausal health and current lifestyle practices in weight gain., Few studies have used self-developed questionnaires for preliminary assessment only, as they suffer from fundamental limitations like lack of validity and reliability. Other valid and reliable methods such as comprehensive lists of valid questionnaires and recall methods are resource-intensive, time-consuming, and complex to interpret in a resource-constrained clinical setting., We aimed to develop and validate an easy-to-administer comprehensive evaluation tool to assess women-centric risk factors for weight gain, weight-related perceptions, and practices of middle-aged women.
| Methodology|| |
This is a mixed-method study conducted in two phases: (i) development of the questionnaire and (ii) validation of developed questionnaire using standardized methodology., The first phase focuses on developing the questionnaire by generating items from literature review and focus group discussions with experts and the target population. In the second phase, the validity and reliability of the developed questionnaire were established using four steps in a sequential manner: expert evaluation to determine content validity, cognitive interviewing to establish face validity, factor analysis to evaluate construct validity, and internal consistency to evaluate reliability. For the purpose of this study, menopausal transition was defined as the phase immediately before and up to 1 year after the final menstrual period, which can range from 2 to 10 years in midlife women. Early menopause was defined as up to 5 years after the final menstrual period.
The study was approved by the Institutional Ethics Committee and informed consent was taken from the participants at the time of recruitment in different phases of the study.
Phase 1: Questionnaire development
In the first phase, two steps were undertaken for the purpose of generating items for developing the questionnaire: (i) systematic review of relevant literature on the given topic and (ii) focus group discussions with subject matter experts and target groups.
First, the research team identified the relevant keywords for literature review through discussion and preliminary search of index terms. The following keyword string was generated: (Obese * OR “Weight gain” OR Overweight) AND (Menopaus * OR Postmenopausal OR Perimenopausal OR “Middle age”) AND (“Risk Factor” OR Determinants OR Predictors OR “Behavioral Factors” OR “Psychological Factors”) AND (Questionnaire OR Scale) and was searched on PubMed and Wiley. A total of 27 studies were identified through title and abstract screening. Finally, after reading the full-text articles (independently by SC and AM), 36 items were generated for the questionnaire.
Second, the research team planned focus group discussions for item generation.,, Initially, five focus groups discussions were conducted among women at menopausal transition and early menopause, and subsequently one focus group discussion was held with experts. In five discussions, a total of 25 women from different socio-economic and cultural groups were invited. The discussions were conducted till an exhaustive list of 45 items was generated on risk factors, perceptions, attitudes, and practices related to appropriate weight management. Following that, one discussion was planned with experts (n = 7) from clinical specialties (Nutrition, Gynecology, Endocrinology, Medicine, Psychology) related to weight management in midlife women. In addition to existing items, this discussion contributed 14 new items to the questionnaire.
Finally, all the generated items were developed into questions. The research team focused on generating close-ended questions in simple language, addressed in the first person, for clarity and understanding. Each item represented a single concept. Double meaning and negatively framed items were avoided. Special attention was also given to the appropriate sequencing of the questions. The items were arranged into the preidentified domains: Menopausal status and symptom severity, readiness to initiate weight loss, perception, and practices related to diet, activity and sleep behavior, and social support.
Phase 2: Validation of developed questionnaire
The validation of the developed questionnaire was established in three steps: expert evaluation, cognitive interviewing, and factor analysis for evaluating content, face, and construct validity.,,
In the first step, a discussion was planned with the subject matter experts (n = 7) to establish the content validity of the developed questionnaire. Each item was rated and discussed in detail on the parameters: relevance, clarity, and simplicity. For the purpose of quantitative analysis, Item Wise-Content Validity Index (I-CVI) was determined based on the number of experts rating the items considering items as relevant, clear, and simple (rating items as 3/4 on a 4-point Likert scale) in comparison to the total number of experts. I-CVI can range from 0 to 1. The items with a rating of <0.70 were eliminated, 0.70–0.79 were modified and 0.79 were accepted without modification. A total of 7 items were removed on the basis of I-CVI calculations. For qualitative assessment, experts' suggestions on framing and sequencing, rewording, rephrasing, and elimination of words in required items were incorporated. In accordance with their suggestions, three items were reframed, five items were reworded and six repetitive items were removed. The remaining items had a 5-point Likert scale rating, assuming equal distance between the responses.
After incorporating the expert's suggestions, the questionnaire was administered via cognitive interviewing technique in the target population for establishing face validity. The interview schedule was planned to understand whether the midlife women were able to comprehend the questionnaire items clearly as intended by the research team. Ten women were recruited via the purposive sampling technique. These women were asked to fill out the questionnaire and rate the items as clear (1) and unclear (0). The unclear items were read out aloud by the interviewer and the participants were probed to verbalize their thoughts on these items. Participant's suggestions included: rewording, limited use of technical terms, using layman language, and formatting of instructions for the existing items. In accordance with the suggestions, two items were reworded, four items were rephrased and three items were removed.
In the third step, the construct validity of the questionnaire was established using factor analysis. The sample size was calculated for establishing the latent construct of the questionnaire on the basis of the rule of thumb of minimum of five participants per scale item. For this purpose, the final questionnaire was administered on a convenience sample of 215 women recruited through the purposive sampling technique. Midlife women between the age of 43–55 years without any chronic and/or end-stage organ disease, and who can read and understand Hindi and English were recruited for this study. At the time of recruitment, these women were briefed about the purpose, objective and their role in the study, and informed consent was taken. The questionnaire was administered via an interview schedule. For the purpose of convenience, the responses were directly noted in the web-based survey designed on Google Forms by the investigator.
The responses were analyzed using exploratory factor analysis to establish the subdomain structure of the questionnaire using SPSS (version 25, IBM Corp, Armonk, NY, USA, 2017). The sampling adequacy of the dataset was assessed using Kaiser-Mayer-Olkin (KMO) measure, a value of more than 0.5 showed that the dataset was suitable for factor analysis. The Barlett's sphericity test assesses the significance of all correlations in the correlation matrix, with a value of <0.05 indicating the dataset suitable for factor analysis. Factor analysis reduces the dimensionality of a large number of items into fewer factors. Exploratory factor analysis with orthogonal rotation (varimax) was used to assess the factors in our dataset. The reliable factors were identified using an Eigenvalue (i.e., variability between items of a single factor) of 1.,
The reliability was established by internal consistency. The internal consistency assesses the extent to which items measure the same thing. The internal consistency was measured using Cronbach's ɑ, a value of more than 0.7 is considered acceptable.
| Results|| |
The final valid and reliable questionnaire has two sections and is freely available for use [Box 1]. Section A consists of sociodemographic profile, anthropometric parameters, and 8-items on menopausal status with symptom severity. The menopausal symptom severity was rated on a 5-point Likert scale ranging from none (0) to very severe (4). A composite menopausal symptom severity score was obtained for all the symptoms to identify overall menopausal symptom severity status. Section B consists of a total of 32-items on readiness to initiate weight loss, perceptions, and practices related to lifestyle-related behaviors, built environment, and social support. The administration time of the questionnaire in an interview schedule is 12–15 min. The responses were marked on a 5-point Likert scale, assuming equal distance between the response options. The most favorable response was rated as the highest score (5) and the least favorable response was rated as the lowest score (1).
Sociodemographic characteristics of the participants
The demographic details of 215 midlife aged women are given in [Table 1]. The mean age was 47.7 ± 4.2 years, with slightly more than half of the participants within the age category of 43–47 years (53.9%). Three-fourths of women were homemakers (76.74%) residing in metropolitan areas (60.47%) and cities (32.5%). The sample had an almost similar proportion of women representing different stages of menopause marked by: regular periods (34.8%), irregular periods (33.4%) and stopping of periods (31.63%) as per the Stages of Reproductive Aging Workshop Criteria. The mean body mass index was 28.58 ± 4.19 kg/m2, with more than three-fourths of women in the obese category (81.86%).
Construct validity of the questionnaire
Factor analysis via principal component analysis and varimax rotation was undertaken to find the reduced factors. Eigenvalue and scree plot was used to identify tenable factors. Considering eigenvalue >1, we found a 11 factor solution explaining 62.13% of the total variance (KMO = 0.699, Bartlett's test of sphericity P < 0.001). The loading of items on different factors is shown in [Supplementary Table 1]. Two items, i.e., q14 and q17 (difficulty in following healthy eating patterns due to mismatched eating habits of family and skipping meals to lose weight) were removed during factor analysis as they did not load on the factor loading axis.
Reliability of the questionnaire
The questionnaire was found to have a good internal consistency with Cronbach's alpha value of 0.79.
| Discussion|| |
We have developed a comprehensive evaluation tool for initial screening of midlife women to recommend appropriate weight management measures. The questionnaire enables a quick assessment of three important risk factors of weight gain in midlife women: (i) menopausal health decided as per the regularity of menstrual cycles and severity of menopausal symptoms, (ii) lifestyle-related behaviors such as eating, activity and sleep habits and (iii) midlife specific barriers in maintaining healthy lifestyle.
The developed questionnaire has several unique features. The questionnaire assesses readiness to lose weight in midlife women. According to the 5As framework for weight management, it is critical to understand women's readiness to initiate weight reduction measures to plan the next steps for managing weight. Oftentimes, women who are eager to participate in weight loss programs have different weight-related perceptions in comparison to their counterparts., The questionnaire gathers information on a woman's perception of her own body weight, experiences related to previous weight loss attempts, and the need to uptake lifestyle modification for managing excessive weight. An understanding of these experiences is important to predict if the woman will make a focused attempt at losing weight and stick to management advice, especially when faced with challenges in her weight loss journey. The questionnaire also aims to identify midlife specific barriers faced at home (mismatched eating pattern, religious fasting, and participation in household chores), work (lack of time, distress), and social (lack of social support, social eating, and access to parks) settings that hinders maintaining day-to-day lifestyle in a way that supports weight loss.,,
In current literature, certain studies have assessed weight gain during the menopausal transition in midlife women. Most studies administered mainly three assessment methods: (i) self-developed surveys, (ii) list of valid and reliable questionnaires and (iii) recall methods for dietary intake and activity. Self-developed surveys are multidimensional and quick to administer, but lack validity and reliability. In order to produce valid and reliable data, studies administered lists of validated questionnaires such as Depression, Anxiety and Stress Scale-21 to measure distress, Body Shape Questionnaire to measure body image issues, and Woman's Health Questionnaire for menopausal quality of life., Often these questionnaires are administered in combination with recall methods such as 24-h recall and Global Physical Activity Assessment Questionnaire for assessing dietary and activity status., Both these assessment methods possess a high participation burden and require expertise for administration. This limits the application of available questionnaires by doctors from different specialties for assessing women presenting with obesity at their outpatient departments, especially in resource-constrained settings.
The application of the questionnaire is manifold. The questionnaire is a concise, easy-to-use, freely available tool for doctors from various specialties for a quick and comprehensive baseline assessment. The questionnaire can be administered by clinicians and allied healthcare professionals, where referral to a dedicated weight management team including dietitians, exercise physiologists, and psychologists for in-depth assessment of these women might not be feasible. The information generated by the questionnaire can be used to generate empirically based, effective women-centric interventions for recommending meaningful, practical, and sustainable weight loss solutions.
Although, it should be noted that the validity and reliability of the questionnaire were established based primarily on responses from the women in the age category of 43–55 years, which depicts a part of the midlife period. In further studies, authors would try to incorporate women between the age categories of 40–65 years to include the varied perspective across the sample population.
| Conclusion|| |
In summary, this newly developed valid and reliable questionnaire enables the comprehensive examination of women-centric risk factors of weight gain and lifestyle practices related to its management in association with menopausal health among midlife women. This questionnaire has a relatively low participant burden and can be administered across diverse socioeconomic groups within the midlife women population. Furthermore, the questionnaire will enable future cross-sectional or longitudinal assessment of lifestyle-related practices and other weight-related parameters in a large cohort of midlife women. The generated evidence can be used to customize current weight management protocols to better suit the stage of the life cycle and lifestyle of midlife women for successful and sustainable weight loss outcomes.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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