An interventional study of Enhanced Lifestyle Weight Management in Rheumatoid Arthritis, Obesity and Pain, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-01-29.
Sponsored by Duke University · Not applicable, Interventional, and Other
This study will test an enhanced lifestyle behavioral weight management program that integrates pain coping strategies with a lifestyle intervention that we expect to enhance obese RA patient's ability to cope with pain-related weight challenges. In the proposed study, up to 120 obese (RA-BMI > 28) rheumatoid arthritis patients will be consented in order to randomly assign 80 patients to one of two conditions: 1) an Enhanced Lifestyle Weight Management protocol or 2) standard care control. Patients randomized to the Enhanced Lifestyle Weight Management condition will participate in a 12-week protocol in which training in coping skills to increase self-efficacy and decrease the impact of RA pain on behavioral (e.g., activity, eating) and psychosocial (e.g., mood, relationships) weight loss factors will be integrated into a lifestyle behavioral weight loss intervention.
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Exclusion Criteria:
The Enhanced Lifestyle Weight Management condition participants participated in a 12-week protocol in which training in coping skills to increase self-efficacy and decrease the impact of RA pain on behavioral (e.g., activity, eating) and psychosocial (e.g., mood, relationships) weight loss factors was integrated into a lifestyle behavioral weight loss intervention.
Behavioral: Enhanced Lifestyle Weight Management
Participants received standard care of rheumatoid arthritis.
The Enhanced Lifestyle Weight Management program was a 12-week protocol in which training in coping skills to increase self-efficacy and decrease the impact of RA pain on behavioral (e.g., activity, eating) and psychosocial (e.g., mood, relationships) weight loss factors were integrated into a lifestyle behavioral weight loss intervention.
Change in weight
Participants' weight was obtained.
Time frame: baseline and post-treatment (12-weeks later)
Change in waist circumference
Participants' waist circumference was measured with a standard measuring tape.
Time frame: baseline and post-treatment (12-weeks later)
Change in body mass index
Participants' body mass index was calculated by dividing weight (in kg) by height (in m2)
Time frame: baseline and post-treatment (12-weeks later)
Change in pain as measured by the Brief Pain Inventory
Pain was assessed with the Brief Pain Inventory, which includes four items asking subjects to rate their usual, worst, least, and average pain during the last week. For each item, patients rate their pain using a scale ranging from 1 to 10 with 1 representing "no pain" and 10 representing "pain as bad as you can imagine."
Time frame: baseline and post-treatment (12-weeks later)
Change in Physical Disability
Participants completed the physical functioning scales of the revised Arthritis Impact Scales (AIMS-2). The AIMS-2 assesses the health status of arthritis patients. Scores range from 0 to 10 with 10 representing reduced physical functioning.
Time frame: baseline and post-treatment (12-weeks later)
Change in Psychological Disability
Participants completed the psychological functioning scale of the revised Arthritis Impact Scales (AIMS-2). The AIMS-2 assesses the health status of arthritis patients. Scores range from 0 to 10 with 10 representing reduced physical functioning.
Time frame: baseline and post-treatment (12-weeks later)
Change in C-Reactive Protein
Serum samples were collected for CRP analysis. All blood specimens were collected in the morning and prior to exercise, centrifuged at 3500 rpm for 10 minutes, and serum stored at -80 degrees Celsius until analysis. CRP is an index of inflammation and activity in RA and is thought to be a more specific measure than erythrocyte sedimentation rate.
Time frame: baseline and post-treatment (12-weeks later)
Change in Cyclic citrullinated peptide (CCP) antibody
Cyclic cirtrullinated peptide (CCP) antibody test that is increasingly being used to measure rheumatoid arthritis disease activity, was collected from the eBrowser when available.
Time frame: baseline and post-treatment (12-weeks later)
Change in physical disability
The 6 minute walk test was used as an objective assessment of physical disability. This was performed indoors in our lab space, along a long, flat, straight, enclosed corridor. A starting line which marks the beginning and end of each lap was marked on the floor with a brightly colored tape.
Time frame: baseline and post-treatment (12-weeks later)
Change in rheumatologist Pain Assessment
The study rheumatologist completed a visual analog scale (VAS) for pain assessment. The VAS was a horizontal line 100 mm in length with anchors ranging from 0 "no disease activity" to 100 "high disease activity."
Time frame: baseline and post-treatment (12-weeks later)
Change in joint symptoms
Two joint counts-of tenderness to palpation and of swelling-were obtained by the examining rheumatologist. As suggested by Fuchs and Pincus, we used a reduced count of 28 joints, and counts rather than grading of tenderness and swelling were made, as advocated by Felson et al. (29), to increase inter-observer reliability.
Time frame: baseline and post-treatment (12-weeks later)
Change in grip strength
Grip strength was assessed using a sphygmomanometer bulb specially designed for this purpose. Three trials with each hand were conducted, with the average of the three being the person's score.
Time frame: baseline and post-treatment (12-weeks later)
Change in medication use
A structured interview was carried out by the study rheumatologist at each evaluation to assess subjects' intake of medication. Subjects were asked what medications they have taken in the two weeks prior to the evaluation. Changes in intake of five categories of medication were scored by comparing data with that collected prior to treatment. The categories included will be 1) nonsteroidal anti-inflammatory drugs, 2) non-narcotic analgesics, 3) narcotics, 4) steroids, and 5) disease modifying anti-rheumatic drugs. Changes in medication were scored as dose increased, dose unchanged, or dose decreased. Based on prior research, we do not anticipate significant changes in medication to occur over the course of the study.
Time frame: baseline and post-treatment (12-weeks later)
Change in Arthritis Self-Efficacy Scale (ASES)
The Arthritis Self-Efficacy Scale (ASES) was used to assess subjects' perceived abilities to perform behaviors that would control arthritis pain and minimize disability. The ASES is a widely used instrument and has been shown to be reliable and valid. Responses for each item range from 10 to 100 where 10 is "very uncertain" and 100 is "very certain."
Time frame: baseline and post-treatment (12-weeks later)
Change in self-efficacy for weight control
The Weight Efficacy Life-Style Questionnaire (WEL) is a 20-item scale used to assess subjects' perceived ability to control their weight by resisting eating across five situations (i.e., positive emotions, negative emotions, food availability, social context, physical discomfort). The WEL has demonstrated good reliability and validity. The 20-item measure asks participants to provide information about how certian they are that they can resist overeating across five situations. Response choices range from 0="not at all confident" to 9= "very confident."
Time frame: baseline and post-treatment (12-weeks later)
Change in Pain Catastrophizing
Pain catastrophizing was measured using the 13-item Pain Catastrophizing Scale (PCS). This scale measures subjects' tendencies to ruminate about pain, magnify pain, and feel helpless about pain. Participants are provided with a list of thoughts and feelings about pain and are asked to rate the degree to which they have these thoughts/feelings on a scale from 0=not at all to 4=all the time.
Time frame: baseline and post-treatment (12-weeks later)
Change in Physical activity
The International Physical Activity Questionnaire (IPAQ) was used to assess change in physical activity. The IPAQ is a short assessment tool that is widely used in adult populations with chronic conditions that asks about individuals' engagement in vigorous, moderate, walking, and sedentary activity over the last 7 days.
Time frame: baseline and post-treatment (12-weeks later)
Change in eating behavior.
Tendencies to overeat or binge eat was measured with the Binge Eating Scale (BES). This is a self-report, 16-item questionnaire with multiple choice statements assessing how severely a person overeats. Weights are assigned to each response option ranging from 0 to 3. Higher scores indicate greater severity of over eating.
Time frame: baseline and post-treatment (12-weeks later)
Change in Mood
Mood changes were assessed with the condensed version of the Profile of Mood States-B (POMS). This measure uses nine adjective to assess negative and positive mood states.
Time frame: baseline and post-treatment (12-weeks later)
Change in relationship satisfaction
Relationship satisfaction was measured with the Interpersonal Support Evaluations List - Short Form (ISEL-SF). This measure includes 16 items that assess perceived support from significant others in these areas: 1) availability of someone to talk to about problems, 2) tangible or instrumental support, 3) belonging support, people available to do things with, and 4) self-esteem support.
Time frame: baseline and post-treatment (12-weeks later)
Change caloric intake
Daily food diaries were collected for four consecutive days following each assessment. Participants were sent home with a structured paper diary and asked to record all caloric intake (food and drink) over the four days. Participants were given instructions on how to record their food and will be instructed to contact study staff if they have any questions during the days they are recording their food.
Time frame: baseline and post-treatment (12-weeks later)
Plan to share: No
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